Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as hydroxychloroquine, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether imatinib mesylate is more effective when given with or without hydroxychloroquine in treating patients with chronic myeloid leukemia.

PURPOSE: This randomized phase II trial is studying the side effects of giving imatinib mesylate with or without hydroxychloroquine and to see how well it works in treating patients with chronic myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lynn McMahon
• Collaborators: CRUK Trials unit Glasgow; Medical Research Council
• Treatments: Hydroxychloroquine; Imatinib Mesylate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic myeloid leukemia (CML) in chronic phase (CP)

• Has been treated with imatinib mesylate for at least 1 year

• Receiving a stable dose for ≥ 6 months prior to randomization

• Achieved at least major cytogenetic response (MCyR) and continues to be BCR/ABL-positive by quantitative polymerase chain reaction (Q-PCR)

• Must have a fusion gene present that can be monitored by Q-PCR

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm³ (stable and within normal range for ≥ 2 months)

• Platelet count ≥ 100,000/mm³ (stable and within normal range for ≥ 2 months)

• Serum albumin > 3 g/dL

• AST and/or ALT ≤ 2.5 times upper limit of normal (ULN)

• Serum bilirubin ≤ 1.5 times ULN

• Serum creatinine ≤ 1.5 times ULN OR 24-hour creatinine clearance ≥ 50 mL/min

• Serum potassium ≥ lower limit of normal with or without replacement therapy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception (including a barrier method [i.e., condom]) during and for 3 months after completion of study therapy

• No impaired cardiac function, including any of the following:

• QTc > 450 msec on screening ECG

• Congenital long QT syndrome

• History or presence of sustained ventricular tachycardia

• History of ventricular fibrillation or Torsades de pointes

• NYHA class III-IV congestive heart failure

• Uncontrolled hypertension

• No severe gastrointestinal (GI) disorder, uncontrolled epilepsy, known glucose-6-phosphate dehydrogenase (G6PD) deficiency, known porphyria, moderate or severe psoriasis, known myasthenia gravis, or other concurrent severe and/or uncontrolled medical conditions

• No preexisting maculopathy of the eye

• No significant history of noncompliance to medical regimens or the inability to grant a reliable informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy, investigational drug, or major surgery and recovered

• More than 6 months since change in imatinib mesylate dose

• No other concurrent anticancer therapy or radiotherapy