Trial Outcomes & Findings for Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma (NCT NCT00299182)
NCT ID: NCT00299182
Last Updated: 2021-09-21
Results Overview
Blood counts were performed at least two times a week and when clinically indicated during the study and daily when PLT count is \< 50K/μL until recovery (two consecutive counts showing upward trend). The optimal biologic dose was defined as the dose of AMG 531 at which the greatest proportion of patients avoided grade 4 thrombocytopenia (Platelet nadir \< 25K/μL) in the absence of platelet transfusion in the blinded study cycle.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)
Results posted on
2021-09-21
Participant Flow
Recruitment Period: March 2, 2006 to February 1, 2010. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
The protocol is designed to combine the placebo of Arm A and Arm B.
Participant milestones
| Measure |
1 mcg/ kg AMG531 Pre & Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Pre & Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Pre & Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Placebo (Arm A & Arm B) With Chemotherapy
Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
1 mcg/ kg AMG531 Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
6
|
14
|
8
|
7
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
4
|
14
|
5
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
3
|
3
|
1
|
Reasons for withdrawal
| Measure |
1 mcg/ kg AMG531 Pre & Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Pre & Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Pre & Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Placebo (Arm A & Arm B) With Chemotherapy
Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
1 mcg/ kg AMG531 Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Post Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Chemotherapy Changed
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Not Eligible
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
1 mcg/ kg AMG531 Pre & Post Chemotherapy
n=6 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Pre & Post Chemotherapy
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Pre & Post Chemotherapy
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Placebo (Arm A & Arm B) With Chemotherapy
n=14 Participants
Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
1 mcg/ kg AMG531 Post Chemotherapy
n=5 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Post Chemotherapy
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Post Chemotherapy
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
14 participants
n=7 Participants
|
5 participants
n=31 Participants
|
4 participants
n=30 Participants
|
4 participants
n=3 Participants
|
41 participants
n=6 Participants
|
|
Age, Continuous
|
57 years
n=99 Participants
|
58 years
n=107 Participants
|
59 years
n=206 Participants
|
56 years
n=7 Participants
|
51 years
n=31 Participants
|
57 years
n=30 Participants
|
56 years
n=3 Participants
|
56 years
n=6 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
32 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)Blood counts were performed at least two times a week and when clinically indicated during the study and daily when PLT count is \< 50K/μL until recovery (two consecutive counts showing upward trend). The optimal biologic dose was defined as the dose of AMG 531 at which the greatest proportion of patients avoided grade 4 thrombocytopenia (Platelet nadir \< 25K/μL) in the absence of platelet transfusion in the blinded study cycle.
Outcome measures
| Measure |
Arm A 1mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
ARM A 3mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm A 10mcg/kg
n=12 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm B 1mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm B 3mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm B 10mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Placebo
n=12 Participants
Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
|---|---|---|---|---|---|---|---|
|
Platelet (PLT) Nadir
|
20.3 K/μL
Standard Error 3.0
|
26.3 K/μL
Standard Error 11.1
|
24.8 K/μL
Standard Error 13.0
|
22.5 K/μL
Standard Error 8.9
|
18.3 K/μL
Standard Error 6.3
|
8 K/μL
Standard Error 2.2
|
11.3 K/μL
Standard Error 1.4
|
PRIMARY outcome
Timeframe: Prior to start of treatment and then at least 2 times a week during treatment until end of cycle 2 (1 cycle = 21 days)The optimal biologic dose was defined as the dose of AMG 531 at which the greatest proportion of patients avoided grade 4 thrombocytopenia (Platelet nadir \< 25K/μL) in the absence of platelet transfusion in the blinded study cycle.
Outcome measures
| Measure |
Arm A 1mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
ARM A 3mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm A 10mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm B 1mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm B 3mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Arm B 10mcg/kg
n=4 Participants
Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by either 1 mcg/kg or 3 mcg/kg or 10 mcg/kg AMG531 subcutaneously on days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Placebo
n=12 Participants
Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy Cycle 1, Chemotherapy (R-HyperCVAD) alone. Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B) R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
|---|---|---|---|---|---|---|---|
|
Days Platelets Count of < 100K/μL
|
5.5 days
Standard Error 0.9
|
5.3 days
Standard Error 1.1
|
8.3 days
Standard Error 2.3
|
6.8 days
Standard Error 1.7
|
8 days
Standard Error 0.8
|
9.3 days
Standard Error 2.0
|
9.8 days
Standard Error 0.7
|
Adverse Events
1 mcg/ kg AMG531 Pre & Post Chemotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
3 mcg/ kg AMG531 Pre & Post Chemotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10 mcg/ kg AMG531 Pre & Post Chemotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo (Arm A & Arm B) With Chemotherapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
1 mcg/ kg AMG531 Post Chemotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
3 mcg/ kg AMG531 Post Chemotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 mcg/ kg AMG531 Post Chemotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 mcg/ kg AMG531 Pre & Post Chemotherapy
n=6 participants at risk
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Pre & Post Chemotherapy
n=4 participants at risk
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Pre & Post Chemotherapy
n=4 participants at risk
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days -5 and 5 (Arm A)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
Placebo (Arm A & Arm B) With Chemotherapy
n=14 participants at risk
Placebo Pre and Post (Arm A), or Post (Arm B) Chemotherapy
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by placebo subcutaneously on days -5 and 5 (Arm A) or days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
1 mcg/ kg AMG531 Post Chemotherapy
n=5 participants at risk
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 1 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
3 mcg/ kg AMG531 Post Chemotherapy
n=4 participants at risk
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 3 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
10 mcg/ kg AMG531 Post Chemotherapy
n=4 participants at risk
Cycle 1, Chemotherapy (R-HyperCVAD) alone.
Cycle 2, Chemotherapy (R-Ara-C/MTX), followed by 10 mcg/ kg AMG 531 subcutaneously on days 5 and 7 (Arm B)
R-HyperCVAD alternating with R-Ara-C/MTX where R-HyperCVAD is Rituximab 375 mg/m\^2; plus Cyclophosphamide 300 mg/m\^2, Vincristine 1.4 mg/m\^2, Doxorubicin (Adriamycin) 50 mg/m\^2, and Dexamethasone 40 mg (CVAD), Mesna 600mg/m\^2; and, R-Ara-C/MTX is Rituximab 375 mg/m\^2, Cytarabine 3 g/m\^2 and Methotrexate 200 mg/m\^2.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/14 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/5 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
25.0%
1/4 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/14 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/5 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
|
General disorders
Myalgia
|
0.00%
0/6 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/14 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/5 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
25.0%
1/4 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/14 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/5 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
25.0%
1/4 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
25.0%
1/4 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
7.1%
1/14 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/5 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
7.1%
1/14 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/5 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
0.00%
0/4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
50.0%
3/6 • Number of events 3 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
50.0%
2/4 • Number of events 2 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
100.0%
4/4 • Number of events 4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
28.6%
4/14 • Number of events 4 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
20.0%
1/5 • Number of events 1 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
50.0%
2/4 • Number of events 2 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
50.0%
2/4 • Number of events 2 • Toxicity assessments with each dose level/cycle (3 week cycle) up to 6 cycles; overall study treatment period four years and three months.
|
Additional Information
Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7966
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place