Status unknownNCT01227135Updated Nov 30, 2011

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

A Phase 2 interventional study of hydroxychloroquine and imatinib mesylate in Leukemia, sponsored by Lynn McMahon. Status unknown at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-30.

Sponsored by Lynn McMahon · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 in major cytogenetic response (MCyR) with residual BCR/ABL-positive cells detectable by quantitative polymerase chain reaction after at least one year of imatinib mesylate treatment.
To determine the safety and tolerability of this regimen in these patients.

Secondary

To determine whether the introduction of HCQ influences imatinib mesylate plasma levels.
To determine if whole blood HCQ levels achieved in combination with imatinib mesylate are in the expected range.
To determine if HCQ inhibits autophagy in vivo.
To evaluate the effects of this regimen on residual BCR/ABL-positive primitive progenitors.

OUTLINE: This is a multicenter study. Patients are stratified according to baseline polymerase chain reaction (PCR) level (\< 3 logs below baseline vs ≥ 3 logs below baseline), time on imatinib mesylate (12 to \< 24 months vs 24 to \< 36 months), imatinib mesylate dose (\< 400 mg vs 400 mg to \< 600 mg vs 600 mg to 800 mg), and center. Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive oral imatinib mesylate daily. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.
Arm B: Patients receive oral imatinib mesylate daily and oral hydroxychloroquine (HCQ) twice daily. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

In both arms, patients may then receive oral imatinib mesylate daily for another 12 months during the follow up period of this study.

Consenting patients undergo blood sample and bone marrow collection at baseline, during, and after completion of study therapy for pharmacologic and other laboratory studies.

After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.

Peer Reviewed, Funded by MRC and supported by Cancer Research UK

Conditions studied

Leukemia

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Keywords

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

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 66 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

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Lead sponsor

This is the only study on the registry with Lynn McMahon as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Masking: None (open label)
Enrollment: 66 participants (estimated)

Interventions

Drughydroxychloroquine
Drugimatinib mesylate
Geneticcytogenetic analysis
Geneticpolymerase chain reaction
Otherlaboratory biomarker analysis
Otherpharmacological study

What researchers measure

Primary outcomes

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

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

Study locations

3 of 3 sites recruiting

Royal Liverpool University Hospital
Liverpool, England L7 8XP, United Kingdom
- Contact Person · Contact · r.e.clark@liverpool.ac.uk · 44-151-706-4297
Recruiting
Imperial College London
London, England W12 0HS, United Kingdom
- Contact Person · Contact · d.marin@imperial.ac.uk · 44-20-8383-1627
Recruiting
Gartnavel General Hospital
Glasgow, Scotland G12 0YN, United Kingdom
- Contact Person · Contact · t.holyoake@clinmed.gla.ac.uk · 44-141-301-7881
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01227135
Lead sponsor: Lynn McMahon
Collaborators: Medical Research Council, CRUK Trials unit Glasgow
Responsible party: Lynn McMahon (Project Manager, University of Glasgow) — Sponsor-investigator
First posted: Oct 25, 2010
Start date: Mar 2010
Primary completion: Mar 2012 (estimated)
Last update: Nov 30, 2011

Study contacts

Tessa Holyoake, MD

principal investigator · Gartnavel General Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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