Trial Outcomes & Findings for Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia (NCT NCT00038610)
NCT ID: NCT00038610
Last Updated: 2015-09-18
Results Overview
Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease. Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts. Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl. Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2015-09-18
Participant Flow
Recruitment Period: March 28, 2001 to October 04, 2006. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Hyper-CVAD + Imatinib
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Hyper-CVAD + Imatinib
n=54 Participants
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Age, Continuous
|
51 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Of the 54 participants, 39 (72%) presented with de novo disease, 6 (11%) were refractory to standard induction therapy, and 9 (17%) entered the study in complete remission (CR) after one course of standard induction therapy.
Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease. Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts. Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl. Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.
Outcome measures
| Measure |
Hyper-CVAD + Imatinib
n=54 Participants
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Complete Remission
|
42 participants
|
|
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Partial Remission
|
1 participants
|
|
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Molecular Complete Remission
|
17 participants
|
|
Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate
Induction Death
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline to 2-year and 5-yearDisease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.
Outcome measures
| Measure |
Hyper-CVAD + Imatinib
n=54 Participants
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Disease-Free Survival Rate at 2-year and 5-year.
5-year DFS rate
|
43 percentage of participants
|
|
Disease-Free Survival Rate at 2-year and 5-year.
2-year DFS rate
|
49 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 2-year and 5-yearOverall survival (OS) was calculated from the date of initiation of therapy until death.
Outcome measures
| Measure |
Hyper-CVAD + Imatinib
n=54 Participants
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Overall Survival Rate at 2-year and 5-year.
2-year OS rate
|
57 percentage of participants
|
|
Overall Survival Rate at 2-year and 5-year.
5-year OS rate
|
43 percentage of participants
|
Adverse Events
Hyper-CVAD + Imatinib
Serious events: 36 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hyper-CVAD + Imatinib
n=54 participants at risk
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Cardiac disorders
Pericardial and pleural effusion
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
General disorders
Death
|
64.8%
35/54 • Number of events 35 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
Other adverse events
| Measure |
Hyper-CVAD + Imatinib
n=54 participants at risk
Imatinib 600 mg orally days 1-14, course 1, \& 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m\^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m\^2 IV day 4; Vincristine 2 mg IV days 4 \& 11; \& Dexamethasone 40 mg IV or orally daily days 1-4 \& 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m\^2 IV over 2 hours followed by 800 mg/m\^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m\^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m\^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
|
|---|---|
|
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
BILIRUBIN INCREASE
|
3.7%
2/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
5.6%
3/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
CONSTIPATION
|
3.7%
2/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
DEHYDRATION
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
DIARRHEA
|
5.6%
3/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Nervous system disorders
DIZZINESS
|
1.9%
1/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
5.6%
3/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Cardiac disorders
DYSRHYTHMIA
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Blood and lymphatic system disorders
EDEMA
|
11.1%
6/54 • Number of events 8 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
General disorders
FATIGUE
|
5.6%
3/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Infections and infestations
FEVER NEUTROPENIC
|
13.0%
7/54 • Number of events 13 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
General disorders
FEVER WITHOUT NEUTROPENIA
|
5.6%
3/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
GASTRITIS
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
GLUCOSE, SERUM-HIGH
|
7.4%
4/54 • Number of events 5 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Nervous system disorders
HEADACHE
|
11.1%
6/54 • Number of events 7 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
HEMORRHOIDAL BLEED
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
1.9%
1/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
5.6%
3/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Cardiac disorders
HYPOTENSION
|
1.9%
1/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Infections and infestations
INFECTION FEBRILE NEUTROPENIA
|
9.3%
5/54 • Number of events 6 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Infections and infestations
INFECTION NEUTROPENIC
|
3.7%
2/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Infections and infestations
INFECTION WITHOUT NEUTROPENIA
|
5.6%
3/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Musculoskeletal and connective tissue disorders
MOTOR
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
NAUSEA ALONE
|
11.1%
6/54 • Number of events 7 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
General disorders
PLEURITIC PAIN
|
1.9%
1/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
3.7%
2/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Renal and urinary disorders
RENAL GENITOURINARY
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Infections and infestations
WOUND INFECTION
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Infections and infestations
INFECTION
|
7.4%
4/54 • Number of events 5 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Nervous system disorders
SENSORY
|
5.6%
3/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Cardiac disorders
TACHYCARDIA
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Nervous system disorders
SYNCOPE
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
VOMITING
|
7.4%
4/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Gastrointestinal disorders
STOMATITIS
|
1.9%
1/54 • Number of events 4 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
TRANSAMINASE INCREASE
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Vascular disorders
THROMBOSIS/EMBOLISM
|
5.6%
3/54 • Number of events 3 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
General disorders
EPISTAXIS
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Nervous system disorders
SPEECH IMPAIRMENT
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
CREATININE INCREASE
|
3.7%
2/54 • Number of events 2 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Metabolism and nutrition disorders
FIBRINOGEN DECREASE
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
Cardiac disorders
CARDIAC
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
|
General disorders
BACK PAIN
|
1.9%
1/54 • Number of events 1 • Adverse events and serious adverse events were collected from receiving of induction therapy to discontinuation of study drug. Collection period: April, 2001 to June 2013.
|
Additional Information
Naval Daver, MD/Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place