Trial Outcomes & Findings for Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas (NCT NCT02213913)
NCT ID: NCT02213913
Last Updated: 2026-03-11
Results Overview
Number of patients with dose-limiting toxicity (DLT) defined as any grade 4 non-hemaotologic toxicity or any recurrent grade 3 non-hematologic toxicity despite optimal medical management
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Up to 21 days
Results posted on
2026-03-11
Participant Flow
Participant milestones
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Phase I Cohort 1: Dose Level 1
STARTED
|
3
|
0
|
0
|
0
|
|
Phase I Cohort 1: Dose Level 1
COMPLETED
|
3
|
0
|
0
|
0
|
|
Phase I Cohort 1: Dose Level 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase I Cohort 2: Dose Level 2
STARTED
|
0
|
7
|
0
|
0
|
|
Phase I Cohort 2: Dose Level 2
COMPLETED
|
0
|
7
|
0
|
0
|
|
Phase I Cohort 2: Dose Level 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase I Cohort 3: Dose Level 3
STARTED
|
0
|
0
|
5
|
0
|
|
Phase I Cohort 3: Dose Level 3
COMPLETED
|
0
|
0
|
5
|
0
|
|
Phase I Cohort 3: Dose Level 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II Cohort 4
STARTED
|
0
|
0
|
0
|
40
|
|
Phase II Cohort 4
COMPLETED
|
0
|
0
|
0
|
40
|
|
Phase II Cohort 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas
Baseline characteristics by cohort
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.0 years
n=9 Participants
|
54.0 years
n=9 Participants
|
67.6 years
n=18 Participants
|
61.8 years
n=15 Participants
|
61.8 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=18 Participants
|
20 Participants
n=15 Participants
|
30 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
20 Participants
n=15 Participants
|
25 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=15 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=15 Participants
|
6 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
31 Participants
n=15 Participants
|
42 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
5 Participants
n=15 Participants
|
5 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: One patient in cohort 2 was non-evaluable for dose-limiting toxicity.
Number of patients with dose-limiting toxicity (DLT) defined as any grade 4 non-hemaotologic toxicity or any recurrent grade 3 non-hematologic toxicity despite optimal medical management
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=6 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Dose-limiting Toxicity (Phase I)
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Assessed up to 5 yearsTime elapsed between treatment initiation and tumor progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Progression-free Survival
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: 1 yearThe percentage of patients alive and progression-free at 1 year.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Progression-free Survival at 1 Year
|
66.7 percentage of participants
Interval 5.4 to 94.5
|
85.7 percentage of participants
Interval 33.4 to 97.9
|
100 percentage of participants
Interval 47.8 to 100.0
|
85.0 percentage of participants
Interval 69.6 to 93.0
|
PRIMARY outcome
Timeframe: 2 yearsPercentage of patients alive and progression-free at 2 years.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Progression-free Survival at 2 Years
|
66.7 percentage of participants
Interval 5.4 to 94.5
|
71.4 percentage of participants
Interval 25.8 to 92.0
|
100 percentage of participants
Interval 47.8 to 100.0
|
77.5 percentage of participants
Interval 61.2 to 87.6
|
SECONDARY outcome
Timeframe: 18 weeksPercentage of patients alive and progression-free at 18 weeks.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Progression-free Survival at 18 Weeks
|
100 percentage of participants
Interval 29.2 to 100.0
|
85.7 percentage of participants
Interval 33.4 to 97.9
|
100 percentage of participants
Interval 47.8 to 100.0
|
90.0 percentage of participants
Interval 75.5 to 96.1
|
SECONDARY outcome
Timeframe: Up to 18 weeksPartial response (PR) or complete response (CR) by computed tomography (CT) of positron emission tomography/CT and/or resolution of marrow-only involvement (if originally involved), according to the Revised Response Criteria for Malignant Lymphoma and Cheson et al.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Overall Response Rate
|
100 percentage of participants
Interval 29.2 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100 percentage of participants
Interval 47.8 to 100.0
|
90.0 percentage of participants
Interval 76.3 to 97.2
|
SECONDARY outcome
Timeframe: Up to 18 weeksStable disease (SD), PR, or CR by computed tomography (CT) of positron emission tomography/CT and/or resolution of marrow-only involvement (if originally involved)according to the Revised Response Criteria for Malignant Lymphoma and Cheson et al.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Anti-tumor Activity
|
100 percentage of participants
Interval 29.2 to 100.0
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
100 percentage of participants
Interval 47.8 to 100.0
|
90.0 percentage of participants
Interval 76.3 to 97.2
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of responding patients alive and progression free two years later.
Outcome measures
| Measure |
Treatment (Lenalidomide 10 mg, DA-EPOCH-R)
n=3 Participants
Phase I Cohort 1:
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=6 Participants
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 Participants
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=36 Participants
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Duration of Response (Rate at 2 Years)
|
66.7 percentage of participants
Interval 5.4 to 94.5
|
83.3 percentage of participants
Interval 27.3 to 97.5
|
100 percentage of participants
Interval 47.8 to 100.0
|
83.3 percentage of participants
Interval 66.6 to 92.1
|
Adverse Events
Treatment (Lenalidomide 10 mg , DA-EPOCH-R)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
Serious events: 21 serious events
Other events: 39 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Treatment (Lenalidomide 10 mg , DA-EPOCH-R)
n=3 participants at risk
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 participants at risk
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 participants at risk
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 participants at risk
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
32.5%
13/40 • Up to 5 years.
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benigh, malignant and unspecified
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
Other adverse events
| Measure |
Treatment (Lenalidomide 10 mg , DA-EPOCH-R)
n=3 participants at risk
INDUCTION PHASE: Patients receive lenalidomide 10 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg, DA-EPOCH-R)
n=7 participants at risk
Phase I Cohort 2:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 20 mg, DA-EPOCH-R)
n=5 participants at risk
Phase I Cohort 3:
INDUCTION PHASE: Patients receive lenalidomide 20 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
Treatment (Lenalidomide 15 mg [MTD], DA-EPOCH-R)
n=40 participants at risk
Phase II Cohort 4:
INDUCTION PHASE: Patients receive lenalidomide 15 mg PO daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DA-EPOCH-R: Patients receive etoposide IV continuously on days 1-4, prednisone PO BID on days 1-5, vincristine sulfate IV continuously on days 1-4, doxorubicin hydrochloride IV continuously on days 1-4, cyclophosphamide IV over 15 minutes on day 5, and rituximab IV over 4 hours on day 1 (per institutional guidelines). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION PHASE: Patients who are transplantation (HSCT)-eligible receive BEAM-conditioning regimen followed by autologous (auto)-HSCT or HSCT at the discretion of the treating physician. Patients who do not undergo HSCT in first remission receive lenalidomide maintenance for 12 months.
lenalidomide: Given PO
etoposide: Given IV
prednisone: Given PO
vincristine sulfate: Given IV
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given IV
rituximab: Given IV
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and mediastinal disorder - Other
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
27.5%
11/40 • Up to 5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/3 • Up to 5 years.
|
57.1%
4/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
3/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
80.0%
4/5 • Up to 5 years.
|
32.5%
13/40 • Up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Up to 5 years.
|
71.4%
5/7 • Up to 5 years.
|
60.0%
3/5 • Up to 5 years.
|
80.0%
32/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
3/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
35.0%
14/40 • Up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 5 years.
|
57.1%
4/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
10.0%
4/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
17.5%
7/40 • Up to 5 years.
|
|
Investigations
Aspartate aminotransferase increase
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
25.0%
10/40 • Up to 5 years.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Up to 5 years.
|
85.7%
6/7 • Up to 5 years.
|
60.0%
3/5 • Up to 5 years.
|
57.5%
23/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
17.5%
7/40 • Up to 5 years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Up to 5 years.
|
57.1%
4/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
50.0%
20/40 • Up to 5 years.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
32.5%
13/40 • Up to 5 years.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
25.0%
10/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
40.0%
16/40 • Up to 5 years.
|
|
General disorders
Edema
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
42.5%
17/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
10.0%
4/40 • Up to 5 years.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
80.0%
4/5 • Up to 5 years.
|
65.0%
26/40 • Up to 5 years.
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
25.0%
10/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
10.0%
4/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
32.5%
13/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
25.0%
10/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
52.5%
21/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
35.0%
14/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
22.5%
9/40 • Up to 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
17.5%
7/40 • Up to 5 years.
|
|
Infections and infestations
Infection
|
33.3%
1/3 • Up to 5 years.
|
57.1%
4/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
42.5%
17/40 • Up to 5 years.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 5 years.
|
57.1%
4/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
40.0%
16/40 • Up to 5 years.
|
|
Investigations
Lymphopenia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
22.5%
9/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
47.5%
19/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
3/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
Infections and infestations
Papulopustular rash
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
Nervous system disorders
Peripheral neuropathy
|
100.0%
3/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
80.0%
4/5 • Up to 5 years.
|
67.5%
27/40 • Up to 5 years.
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Up to 5 years.
|
57.1%
4/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
52.5%
21/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
10.0%
4/40 • Up to 5 years.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders - other
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
10.0%
4/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash aceniform
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Investigations
Weight loss
|
33.3%
1/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Eye disorders
Floaters
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
12.5%
5/40 • Up to 5 years.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
25.0%
10/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Urostomy stenosis
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Abdominal distenstion
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea intermittent
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
General disorders
General disorders - Other
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Bilateral leg swelling
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
0.00%
0/40 • Up to 5 years.
|
|
Blood and lymphatic system disorders
Blood and lymphatic tissue disorders - Other
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
60.0%
3/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
20.0%
8/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
40.0%
2/5 • Up to 5 years.
|
27.5%
11/40 • Up to 5 years.
|
|
Investigations
Weight gain
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
15.0%
6/40 • Up to 5 years.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Up to 5 years.
|
28.6%
2/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
22.5%
9/40 • Up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-other
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
7.5%
3/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
32.5%
13/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
2.5%
1/40 • Up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to 5 years.
|
42.9%
3/7 • Up to 5 years.
|
60.0%
3/5 • Up to 5 years.
|
57.5%
23/40 • Up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
10.0%
4/40 • Up to 5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms, benign, malignant and unspecified
|
0.00%
0/3 • Up to 5 years.
|
0.00%
0/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
|
Investigations
Neutropenia
|
100.0%
3/3 • Up to 5 years.
|
71.4%
5/7 • Up to 5 years.
|
20.0%
1/5 • Up to 5 years.
|
65.0%
26/40 • Up to 5 years.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 5 years.
|
14.3%
1/7 • Up to 5 years.
|
0.00%
0/5 • Up to 5 years.
|
5.0%
2/40 • Up to 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60