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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: Imatinib; Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982488

CA180-188

2007-003624-37

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 5 patient groups

Dasatinib, 50 mg QD to 120 mg BID, Chronic phase

Other group

Description:

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).

Treatment:

Drug: Dasatinib

Imatinib, 400 mg BID, Chronic phase

Other group

Description:

Participants with chronic phase disease received 400 mg of imatinib twice BID.

Treatment:

Drug: Imatinib

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP

Other group

Description:

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.

Treatment:

Drug: Dasatinib

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP

Other group

Description:

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.

Treatment:

Drug: Dasatinib

Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL

Other group

Description:

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.

Treatment:

Drug: Dasatinib