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

Study Overview
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Brief Summary
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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.

Official Title
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Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who Are Experiencing Clinical Benefit on Current START or CA180-039 Protocols: Long Term Safety and Efficacy Analysis

Conditions
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Leukemia

Intervention / Treatment
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* Drug: Dasatinib
* Drug: Imatinib


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria Signed written informed consent Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039 Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator Men and women, ages 18 and older Key Exclusion Criteria A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy Dementia or altered mental status that would prohibit the understanding or rendering of informed consent Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dasatinib, 50 mg QD to 120 mg BID, Chronic phase<br>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). | Drug: Dasatinib<br>* Dasatinib was supplied as 20- and 50-mg tablets.<br>* Other names: Src Kinase;|
| Other: Imatinib, 400 mg BID, Chronic phase<br>Participants with chronic phase disease received 400 mg of imatinib twice BID. | Drug: Imatinib<br>* Imatinib was supplied as 100- and 400-mg tablets.<br>* Other names: Gleevec/Glivec;|
| Other: Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP<br>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. | Drug: Dasatinib<br>* Dasatinib was supplied as 20- and 50-mg tablets.<br>* Other names: Src Kinase;|
| Other: Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP<br>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. | Drug: Dasatinib<br>* Dasatinib was supplied as 20- and 50-mg tablets.<br>* Other names: Src Kinase;|
| Other: Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL<br>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. | Drug: Dasatinib<br>* Dasatinib was supplied as 20- and 50-mg tablets.<br>* Other names: Src Kinase;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Day 1 of treatment through a maximum of 82 months + 30 days |