Trial Outcomes & Findings for Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma (NCT NCT03742258)

Last Updated: 2025-06-18

Results Overview

Determine the safety and establish the maximum tolerated dose of TAK-659 when combined with R-CHOP in the front-line treatment of high-risk DLBCL using only patients who are evaluable for dose limiting (DLT) toxicities. MTD for TAK-659 will be determined using a 3+3 dose escalation method. The starting dose was 60 mg with possible escalation to 80 mg and 100 mg. Patients may be de-escalated to 40 mg if DLT's were met at dose level 1.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

The first 21 days after the participant received their first dose of TAK-695

Results posted on

2025-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	TAK-659 60mg + R-CHOP Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 1 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Prednisone: Given PO Rituximab: Given IV Spleen Tyrosine Kinase Inhibitor TAK-659: Given PO Vincristine Sulfate: Given IV	TAK-659 80mg + R-CHOP Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 2 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.	TAK-659 100mg + R-CHOP Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 3 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity
Cycle 1: R-CHOP STARTED	3	3	6
Cycle 1: R-CHOP COMPLETED	3	3	6
Cycle 1: R-CHOP NOT COMPLETED	0	0	0
Reached 1st Response Assessment STARTED	3	3	6
Reached 1st Response Assessment Cycle 2	3	3	6
Reached 1st Response Assessment Cycle 3	3	3	6
Reached 1st Response Assessment Reached 1st Response	3	3	6
Reached 1st Response Assessment COMPLETED	3	3	6
Reached 1st Response Assessment NOT COMPLETED	0	0	0
Continued Treatment After 1st Response STARTED	3	3	6
Continued Treatment After 1st Response Went on to Cycle 4 to End of Treatment	3	3	6
Continued Treatment After 1st Response COMPLETED	3	2	4
Continued Treatment After 1st Response NOT COMPLETED	0	1	2
Survival Follow-Up STARTED	3	3	6
Survival Follow-Up COMPLETED	3	3	4
Survival Follow-Up NOT COMPLETED	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TAK-659 80mg + R-CHOP Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 2 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.	TAK-659 100mg + R-CHOP Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 3 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity
Continued Treatment After 1st Response Adverse Event	1	1
Continued Treatment After 1st Response Withdrawal by Subject	0	1
Survival Follow-Up Still in Follow-up	0	2

Baseline Characteristics

Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAK-659 60mg + R-CHOP n=3 Participants Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 1 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Prednisone: Given PO Rituximab: Given IV Spleen Tyrosine Kinase Inhibitor TAK-659: Given PO Vincristine Sulfate: Given IV	TAK-659 80mg + R-CHOP n=3 Participants Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 1 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.	TAK-659 100mg + R-CHOP n=6 Participants Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 1 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.	Total n=12 Participants Total of all reporting groups
Age, Customized 18-29	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Age, Customized 30-39	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Customized 40-49	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Age, Customized 50-59	1 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants
Age, Customized 60-69	1 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants
Age, Customized 70+	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants	4 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants	7 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	5 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants	8 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants	11 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: The first 21 days after the participant received their first dose of TAK-695

Outcome measures

Outcome measures
Measure	Treatment (R-CHOP, TAK-659) n=12 Participants Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in course 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Prednisone: Given PO Rituximab: Given IV Spleen Tyrosine Kinase Inhibitor TAK-659: Given PO Vincristine Sulfate: Given IV
Maximum Tolerated Dose (MTD)	100 mg TAK-659

SECONDARY outcome

Timeframe: PET/CT after the completion of Cycle 3

Population: The analysis population for this endpoint was defined in the protocol as all patients who completed 1 dose of TAK-659 and had 1 post-baseline disease assessment. Therefore, all 12 patients were analyzed as 1 group irrespective of the dose of TAK-659 they received.

Using Lugano criteria (2014), ORR will be defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) as assessed by the investigators. Response will be assessed by positron emission tomography (PET)/computed tomography (CT).

Outcome measures

Outcome measures
Measure	Treatment (R-CHOP, TAK-659) n=12 Participants Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in course 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Prednisone: Given PO Rituximab: Given IV Spleen Tyrosine Kinase Inhibitor TAK-659: Given PO Vincristine Sulfate: Given IV
Overall Response Rate (ORR)	12 Participants

SECONDARY outcome

Timeframe: Up to 18 months

PFS will be assessed using Kaplan-Meier curves at 12 month and 18 months during survival follow-up.

Outcome measures

Outcome measures
Measure	Treatment (R-CHOP, TAK-659) n=12 Participants Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in course 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Prednisone: Given PO Rituximab: Given IV Spleen Tyrosine Kinase Inhibitor TAK-659: Given PO Vincristine Sulfate: Given IV
Progression Free Survival (PFS) At 12 Months	.825 percentage of progression free survival Interval 0.631 to 1.0
Progression Free Survival (PFS) At 18 Months	.733 percentage of progression free survival Interval 0.515 to 1.0

Adverse Events

TAK-659 60mg + R-CHOP

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

TAK-659 80mg + R-CHOP

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

TAK-659 100mg + R-CHOP

Serious events: 6 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Reem Karmali, MD

Northwestern University

Phone: (312) 695-0711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	TAK-659 60mg + R-CHOP n=3 participants at risk Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 1 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Prednisone: Given PO Rituximab: Given IV Spleen Tyrosine Kinase Inhibitor TAK-659: Given PO Vincristine Sulfate: Given IV	TAK-659 80mg + R-CHOP n=3 participants at risk Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 2 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.	TAK-659 100mg + R-CHOP n=6 participants at risk Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 3 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Infections and infestations Lung infection	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	66.7% 2/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	33.3% 2/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Sinusitis	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	33.3% 1/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	66.7% 4/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	33.3% 2/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Bacteremia	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	33.3% 2/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Endocarditis infective	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	33.3% 2/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Sepsis	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	66.7% 4/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Infections and infestations Thrush	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Nervous system disorders Stroke	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.
Vascular disorders Thromboembolic event	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	0.00% 0/3 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.	16.7% 1/6 • Adverse Events (AEs) were collected over a 2 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment.