A Phase 1/2 interventional study of Imatinib and Hydroxyurea in Leukemia, Myelogenous, Chronic, BCR-ABL Positive, sponsored by University of Leipzig. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by University of Leipzig · Phase 1/2, Interventional, and Treatment
The study will test the tolerability and efficacy of the combination therapy Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic phase (CP1) newly diagnosted or failing interferon-based therapy.
The protocol consists of a part 1, a phase I study that will enrol 20 patients, with the goal to determine the safety of the combination as well as the maximal tolerated dose. If the toxicity of the combination is acceptable, up to 200 more patients may be recruited and randomized to receive either Imatinib/HU or Imatinib alone (part 2).
Patients who meet the inclusion criteria will be started on 400 mg Imatinib daily. In part 1 of the protocol, the dose of HU will be increased by 500 mg at 3-weekly intervals until the maximal tolerated dose has been reached. In part 2 of the study, patients will be randomized to receive either the combination or Imatinib monotherapy.
Hematological and cytogenetic response will be evaluated at 3-months intervals during the first year, and at 6 months' intervals thereafter. Primary endpoints for part 1 are dose-limiting toxicity and maximal tolerated dose. Primary endpoints for part 2 are the rates of major and complete molecular response at 6, 12 and 18 months, respectively.
2,444 studies on the registry are indexed under Leukemia, Myeloid; 210 are open to participants now.
This study's enrollment of 113 is above the median of 40 across 1,978 interventional studies indexed under Leukemia, Myeloid.
Browse Leukemia, Myeloid studies →University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Objective signs of disease progression beyond CP1 defined as
Important note: previous treatment with Imatinib only is not an exclusion criterion for part 1 of the study.
Patients who meet the inclusion criteria will be started on 400 mg Imatinib daily. In part 1 of the protocol, the dose of HU will be increased by 500 mg at 3-weekly intervals until the maximal tolerated dose has been reached. In part 2 of the study, patients will be randomized to receive either the combination or Imatinib monotherapy.
Drug: Imatinib · Drug: Hydroxyurea
Imatinib monotherapy
Drug: Imatinib
number of participants with complete molecular response as a measure of efficacy
complete molecular response is achieved if BCR-ABL (breakpoint cluster region-Abelson murine leukemia) transcripts became undetectable
Time frame: 18 months
No study locations are listed for this record.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Leipzig