EUCTR2005-000813-36-GB
Active, not recruiting
Phase 1
A phase II, multicentre, single-arm, open-label study of subcutaneoushomoharringtonine (HHT) alone in patients with accelerated phase chronicmyeloid leukemia (CML) who are refractory to, or have relapsed on imatinibmesylate
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- STRAGEN France
- Enrollment
- 106
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Male or female patients aged 18 to 80 years.
- •b) Patients diagnosed with Ph chromosome\-positive or BCR\-ABL positive CML in the
- •accelerated phase confirmed by a bone marrow aspirate and/or biopsy including
- •cytogenetics and molecular analysis that must be completed within 28 days prior to
- •initiation of HHT
- •c) Patients who have failed to respond to, or have relapsed on imatinib
- •d) Estimated life expectancy of at least 12 weeks.
- •e) Adequate performance status as defined by a grading of 2 or better on the ECOG
- •Performance Status Criteria
- •f) Female patients of child\-bearing potential willing to use adequate contraception
Exclusion Criteria
- •a) Patients planned for allogeneic transplantation before the end of induction period.
- •b) Prior stem cell transplantation.
- •c) Patients previously treated with combination chemotherapy or autografting for
- •accelerated phase disease.
- •d) Patients with previous blastic phase.
- •e) Subjects previously treated with HHT.
- •f) Female patients who are pregnant (confirmed by a serum pregnancy test) or
- •g) For patients who have received another investigational anti\-leukemic product, a
- •wash\-out period of 2 times half\-life of the product must be observed before initiation
- •of treatment with HHT (at least 48h of wash\-out). In case of grade 3\-4 hematological
Outcomes
Primary Outcomes
Not specified
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