Status:
UNKNOWN
Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia
Lead Sponsor:
Lynn McMahon
Collaborating Sponsors:
Medical Research Council
CRUK Trials unit Glasgow
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 syst...
Detailed Description
OBJECTIVES: Primary * To determine if imatinib mesylate versus hydroxychloroquine (HCQ) and imatinib mesylate is more effective in terms of BCR/ABL levels in patients with chronic myeloid leukemia i...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01227135
Start Date
March 1 2010
Last Update
November 30 2011
Active Locations (3)
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1
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP
2
Imperial College London
London, England, United Kingdom, W12 0HS
3
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom, G12 0YN