Trial Outcomes & Findings for CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL) (NCT NCT01134575)
NCT ID: NCT01134575
Last Updated: 2024-07-16
Results Overview
Primary endpoint for efficacy is response which is defined as: Complete Remission (CR), Complete Remission without recovery of counts (CRi) or Partial Remission (PR). Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x109/L, platelet count \>100x109/L, and normal marrow differential (\< 5% blasts). 8.2 Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 109/L; neutrophils \< 1 x 109/L). Partial remission (PR): Peripheral blood count recovery as for CR, but with decrease in marrow blasts of \> 50% and not more than 25% abnormal cells in the marrow.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
After cycle 2, for up to 8 cycles
Results posted on
2024-07-16
Participant Flow
Recruitment period: June 2010 to October 2012
Participant milestones
| Measure |
Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
45
|
42
|
|
Overall Study
COMPLETED
|
3
|
45
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
Baseline characteristics by cohort
| Measure |
Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
n=3 Participants
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2
n=45 Participants
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
n=42 Participants
CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Continuous
|
32 years
n=5 Participants
|
38 years
n=7 Participants
|
51 years
n=5 Participants
|
40 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
45 participants
n=7 Participants
|
42 participants
n=5 Participants
|
90 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After cycle 2, for up to 8 cyclesPrimary endpoint for efficacy is response which is defined as: Complete Remission (CR), Complete Remission without recovery of counts (CRi) or Partial Remission (PR). Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x109/L, platelet count \>100x109/L, and normal marrow differential (\< 5% blasts). 8.2 Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 109/L; neutrophils \< 1 x 109/L). Partial remission (PR): Peripheral blood count recovery as for CR, but with decrease in marrow blasts of \> 50% and not more than 25% abnormal cells in the marrow.
Outcome measures
| Measure |
Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
n=3 Participants
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2
n=45 Participants
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
n=42 Participants
CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
|---|---|---|---|
|
Number of Patients With Response
|
3 Participants
|
25 Participants
|
24 Participants
|
Adverse Events
Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2
Serious events: 26 serious events
Other events: 29 other events
Deaths: 2 deaths
Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
Serious events: 10 serious events
Other events: 28 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
n=3 participants at risk
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2
n=45 participants at risk
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
n=42 participants at risk
CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
|---|---|---|---|
|
General disorders
Abdominal Pain
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Bilateral Extremity Pain
|
33.3%
1/3 • Number of events 1 • Up to two years
|
0.00%
0/45 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Bone Pain
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Chest Pain
|
33.3%
1/3 • Number of events 1 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Failure to Thrive
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Headache
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Nervous system disorders
Hemorrhage CNS
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Surgical and medical procedures
Laparoscopic Cholecystectomy
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Leukemic CNS Involvement
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Infections and infestations
Neutropenic Fever
|
66.7%
2/3 • Number of events 2 • Up to two years
|
33.3%
15/45 • Number of events 18 • Up to two years
|
14.3%
6/42 • Number of events 9 • Up to two years
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • Up to two years
|
13.3%
6/45 • Number of events 6 • Up to two years
|
9.5%
4/42 • Number of events 5 • Up to two years
|
|
Infections and infestations
Bactremia
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
4.8%
2/42 • Number of events 3 • Up to two years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Syncytial Virus
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
Other adverse events
| Measure |
Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
n=3 participants at risk
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 2: CMC-544 (Inotuzumab Ozogamycin) 1.8mg/m^2
n=45 participants at risk
First patients \> 16 years and \< 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
Period 3: Weekly CMC-544 (Inotuzumab Ozogamycin)
n=42 participants at risk
CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m\^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2.
CMC-544 (Inotuzumab Ozogamycin): First patients \> 16 years and \< 16 years receive CMC-544 at a dose of 1.3 mg/m\^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m\^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m\^2 IV over 1 hour every 4 week cycle.
Rituximab: With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m\^2 IV (by vein) over 2-6 hours every 3-4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Abdominal Pain
|
33.3%
1/3 • Number of events 1 • Up to two years
|
20.0%
9/45 • Number of events 9 • Up to two years
|
14.3%
6/42 • Number of events 6 • Up to two years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to two years
|
11.1%
5/45 • Number of events 5 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
General disorders
Back Pain
|
0.00%
0/3 • Up to two years
|
24.4%
11/45 • Number of events 12 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Metabolism and nutrition disorders
Increased Bilirubin
|
0.00%
0/3 • Up to two years
|
11.1%
5/45 • Number of events 9 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Metabolism and nutrition disorders
Blood Glucose Increased
|
33.3%
1/3 • Number of events 1 • Up to two years
|
8.9%
4/45 • Number of events 6 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/3 • Up to two years
|
13.3%
6/45 • Number of events 7 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Cardiac disorders
Cardiac Arrhythmia
|
33.3%
1/3 • Number of events 1 • Up to two years
|
0.00%
0/45 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Cardiac disorders
Chest Pain
|
33.3%
1/3 • Number of events 1 • Up to two years
|
13.3%
6/45 • Number of events 6 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Up to two years
|
22.2%
10/45 • Number of events 12 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Nervous system disorders
Confusion
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to two years
|
13.3%
6/45 • Number of events 7 • Up to two years
|
16.7%
7/42 • Number of events 7 • Up to two years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to two years
|
15.6%
7/45 • Number of events 7 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Metabolism and nutrition disorders
Creatinine Increased
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 5 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
0.00%
0/3 • Up to two years
|
8.9%
4/45 • Number of events 6 • Up to two years
|
14.3%
6/42 • Number of events 7 • Up to two years
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Up to two years
|
20.0%
9/45 • Number of events 10 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Number of events 2 • Up to two years
|
8.9%
4/45 • Number of events 5 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Eye disorders
Dry Eye Syndrome
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 2 • Up to two years
|
20.0%
9/45 • Number of events 10 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
General disorders
Edema Limbs
|
0.00%
0/3 • Up to two years
|
20.0%
9/45 • Number of events 14 • Up to two years
|
14.3%
6/42 • Number of events 6 • Up to two years
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to two years
|
8.9%
4/45 • Number of events 7 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/3 • Up to two years
|
22.2%
10/45 • Number of events 16 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
General disorders
Fever
|
0.00%
0/3 • Up to two years
|
33.3%
15/45 • Number of events 22 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Gastrointestinal disorders
Gastrointestianl Other
|
0.00%
0/3 • Up to two years
|
8.9%
4/45 • Number of events 5 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
General disorders
Headache
|
0.00%
0/3 • Up to two years
|
33.3%
15/45 • Number of events 18 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Ear and labyrinth disorders
Hearing Loss
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Blood and lymphatic system disorders
Hematoma
|
33.3%
1/3 • Number of events 3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding
|
0.00%
0/3 • Up to two years
|
11.1%
5/45 • Number of events 5 • Up to two years
|
11.9%
5/42 • Number of events 5 • Up to two years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Hepatobiliary disorders
Hepatic Failure
|
33.3%
1/3 • Number of events 1 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas Other
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Number of events 1 • Up to two years
|
0.00%
0/45 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Cardiac disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • Up to two years
|
8.9%
4/45 • Number of events 4 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Up to two years
|
15.6%
7/45 • Number of events 8 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Infections and infestations
Infection
|
66.7%
2/3 • Number of events 2 • Up to two years
|
8.9%
4/45 • Number of events 7 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
General disorders
Insomnia
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Localized Edema
|
33.3%
1/3 • Number of events 1 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Blood and lymphatic system disorders
Lymphatics Other
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
7.1%
3/42 • Number of events 4 • Up to two years
|
|
Blood and lymphatic system disorders
Lymphedema
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
0.00%
0/3 • Up to two years
|
17.8%
8/45 • Number of events 16 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
33.3%
1/3 • Number of events 1 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • Up to two years
|
22.2%
10/45 • Number of events 13 • Up to two years
|
16.7%
7/42 • Number of events 8 • Up to two years
|
|
General disorders
Neck Pain
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Nervous system disorders
Neurology
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
7.1%
3/42 • Number of events 4 • Up to two years
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 4 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Ocular/Visual Other
|
33.3%
1/3 • Number of events 1 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Up to two years
|
24.4%
11/45 • Number of events 20 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
General disorders
Pain Extremity
|
33.3%
1/3 • Number of events 1 • Up to two years
|
26.7%
12/45 • Number of events 14 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/3 • Up to two years
|
11.1%
5/45 • Number of events 5 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
7.1%
3/42 • Number of events 4 • Up to two years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • Up to two years
|
13.3%
6/45 • Number of events 6 • Up to two years
|
9.5%
4/42 • Number of events 4 • Up to two years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to two years
|
13.3%
6/45 • Number of events 6 • Up to two years
|
21.4%
9/42 • Number of events 9 • Up to two years
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Psychiatric disorders
Psychosis
|
33.3%
1/3 • Number of events 1 • Up to two years
|
0.00%
0/45 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Reproductive system and breast disorders
Pulmonary Other
|
33.3%
1/3 • Number of events 1 • Up to two years
|
13.3%
6/45 • Number of events 8 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Skin and subcutaneous tissue disorders
Rash Desquamation
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 5 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
33.3%
1/3 • Number of events 1 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
General disorders
Rectal Pain
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Renal and urinary disorders
Renal/Genitourinary Other
|
0.00%
0/3 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Up to two years
|
6.7%
3/45 • Number of events 4 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Calcium Decreased
|
0.00%
0/3 • Up to two years
|
17.8%
8/45 • Number of events 8 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Glucose Decreased
|
33.3%
1/3 • Number of events 1 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Magnesium Decreased
|
0.00%
0/3 • Up to two years
|
20.0%
9/45 • Number of events 11 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Phosphate Decreased
|
33.3%
1/3 • Number of events 2 • Up to two years
|
17.8%
8/45 • Number of events 12 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Potassium Increased
|
33.3%
1/3 • Number of events 1 • Up to two years
|
4.4%
2/45 • Number of events 2 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Sodium Decreased
|
0.00%
0/3 • Up to two years
|
13.3%
6/45 • Number of events 6 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Metabolism and nutrition disorders
Serum Potassium Decreased
|
0.00%
0/3 • Up to two years
|
26.7%
12/45 • Number of events 17 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Cardiac disorders
Sinus Bradycarida
|
33.3%
1/3 • Number of events 1 • Up to two years
|
0.00%
0/45 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/3 • Up to two years
|
11.1%
5/45 • Number of events 5 • Up to two years
|
0.00%
0/42 • Up to two years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to two years
|
0.00%
0/45 • Up to two years
|
7.1%
3/42 • Number of events 3 • Up to two years
|
|
Vascular disorders
Thrombosis
|
33.3%
1/3 • Number of events 1 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
2.4%
1/42 • Number of events 1 • Up to two years
|
|
General disorders
Toothache
|
0.00%
0/3 • Up to two years
|
2.2%
1/45 • Number of events 1 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Up to two years
|
6.7%
3/45 • Number of events 3 • Up to two years
|
4.8%
2/42 • Number of events 2 • Up to two years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to two years
|
15.6%
7/45 • Number of events 11 • Up to two years
|
9.5%
4/42 • Number of events 5 • Up to two years
|
Additional Information
Hagop M. Kantarnian, MD/Chair
The University of Texas MD Anderson Cancer Center
Phone: 713-792-7026
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place