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

NCT01227135 | Unknown Phase 2 DMC

• 5 other identifiers: CDR0000686729CRUK-H135ISRCTN-61568166EUDRACT-2009-014373-41EU-21078
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive

Outcome Measures

Primary Outcomes (1)

• Proportion of treatment "successes" defined as patients who have at least 0.5 log reductions or more in their 12-month PCR level from baseline

Secondary Outcomes (3)

• Proportion of treatment "successes" at 24 months

• Molecular response at 12 and 24 months (complete response, major response, or no response)

• Proportion of patients with progression at 12 and 24 months

Interventions

hydroxychloroquine DRUG

imatinib mesylate DRUG

cytogenetic analysis GENETIC

polymerase chain reaction GENETIC

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Lynn McMahon: lead
• Medical Research Council: collaborator
• CRUK Trials unit Glasgow: collaborator

Study Sites (3)

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

RECRUITING

Imperial College London

London, England, W12 0HS, United Kingdom

RECRUITING

Gartnavel General Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Hydroxychloroquine; Imatinib Mesylate; Cytogenetic Analysis; Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Pyrimidines; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Nucleic Acid Amplification Techniques

Study Officials

• Tessa Holyoake, MD

  Gartnavel General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: November 30, 2011

Record last verified: 2011-11

Locations

GB (3)