Treatment of CML Patients With Imatinib and Hydroxyurea (CML2004)

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leipzig
• Treatments: Hydroxyurea; Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Ph-positive CML in CP1, newly diagnosed or resistant (hematologic or cytogenetic) or intolerant to interferon-based therapy

2. Age ≥ 18 years

3. Negative pregnancy test

4. Low- and intermediate risk patients younger than 45 with an HLA (Human Leukocyte Antigen) -matched sibling donor and medically fit to undergo allografting should be included only after they have been adequately counselled about the potential risk (of disease progression) associated with delaying the allograft

5. Informed consent

Exclusion Criteria:

1. Objective signs of disease progression beyond CP1 defined as

• bone marrow or peripheral blood blasts > 15% and/or

• blasts + promyelocytes ≥ 30% and/or

• peripheral blood basophils ≥ 20% and/or

• platelets < 100/nl and/or

• chromosomal abnormalities in addition to the Ph chromosome

2. Findings suggestive of extramedullary involvement

3. Any severe and uncontrolled medical condition

4. Previous treatment with Imatinib (only part 2 of the study)

5. History of non-compliance

6. Simultaneous inclusion in other studies

Important note: previous treatment with Imatinib only is not an exclusion criterion for part 1 of the study.