Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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

Locations (18): Pacific Cancer Medical Center Inc
🇺🇸
Anaheim, California, United States
Ucla Department Of Medicine
🇺🇸
Los Angeles, California, United States
John Theurer Cancer Center
🇺🇸
Hackensack, New Jersey, United States
Ut Southwestern Medical Center At Dallas
🇺🇸
Dallas, Texas, United States
Loma Linda University Cancer Center
🇺🇸
Loma Linda, California, United States
Dana Faber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸
Tampa, Florida, United States
Western Pennsylvania Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Kaiser Permanente Medical Center
🇺🇸
Vallejo, California, United States
Wayne State University
🇺🇸
Detroit, Michigan, United States
Local Institution
🇬🇧
Newcastle, Tyne And Wear, United Kingdom
Stanford University School Of Medicine
🇺🇸
Stanford, California, United States
University Of Chicago
🇺🇸
Chicago, Illinois, United States
Central Indiana Cancer Centers
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Indianapolis, Indiana, United States
The University Of Texas Md Anderson Cancer Center
🇺🇸
Houston, Texas, United States
University Of Michigan Medical Center
🇺🇸
Ann Arbor, Michigan, United States
Oregon Health & Sci Univ
🇺🇸
Portland, Oregon, United States
University Of Kansas Medical Center
🇺🇸
Westwood, Kansas, United States