Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT01227135
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.
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
Study:
NCT01227135
Study Brief:
Protocol Section:
NCT01227135