Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- Registration Number
- NCT00982488
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This study assesses the long-term safety and tolerability of dasatinib administered to patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or imatinib in previous protocols.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dasatinib, 50 mg QD to 120 mg BID, Chronic phase Dasatinib Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Imatinib, 400 mg BID, Chronic phase Imatinib Participants with chronic phase disease received 400 mg of imatinib twice BID. Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP Dasatinib Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP Dasatinib Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL Dasatinib Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
- Primary Outcome Measures
Name Time Method Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest Day 1 of treatment through a maximum of 82 months + 30 days AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Pacific Cancer Medical Center Inc
🇺🇸Anaheim, California, United States
Loma Linda University Cancer Center
🇺🇸Loma Linda, California, United States
Ucla Department Of Medicine
🇺🇸Los Angeles, California, United States
Stanford University School Of Medicine
🇺🇸Stanford, California, United States
Kaiser Permanente Medical Center
🇺🇸Vallejo, California, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
University Of Chicago
🇺🇸Chicago, Illinois, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
University Of Kansas Medical Center
🇺🇸Westwood, Kansas, United States
Dana Faber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Scroll for more (8 remaining)Pacific Cancer Medical Center Inc🇺🇸Anaheim, California, United States