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
- Conditions
- Accelerated phase Chronic Myeloid Leukaemia (CML).
- Registration Number
- EUCTR2005-000813-36-GB
- Lead Sponsor
- STRAGEN France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 106
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
(oral contraceptive pill, IUD, surgical sterilization, depot injection, contraceptive
patches or barrier method in combination with a spermicide) for the duration of and
at least one month after the last dose of investigational product.
g) Male patients willing to use adequate contraception for the duration of and at least three months after the last dose of investigational product.
h) Patients who have given written informed consent having read and understood the subject information sheet.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
lactating.
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
toxicity related to any other investigational anti-leukemic product, patients should
not begin treatment with HHT until blood count recovery.
h) Anti-leukemic agents, other than hydroxyurea (HU) or anagrelide, within seven days prior to the initiation of treatment with HHT. Imatinib have to be stopped at least 48 hours before starting therapy with HHT. In case of grade 3-4 hematological toxicity related to imatinib, patients should not begin treatment with HHT until blood counts recovery.
i) NYHA class III or IV heart disease, active ischemia or any other uncontrolled
cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia
requiring therapy, uncontrolled hypertension or congestive heart failure.
j) Creatinine levels more than 3 x ULN (upper limit of normal range) at the laboratory
where the analysis was performed.
k) Total serum bilirubin more than 3 x ULN in subjects without clinically suspected
leukemic involvement of the liver.
l) AST (SGOT) or ALT (SGPT) more than 5 x ULN in subjects without clinically
suspected leukemic involvement of the liver.
m) Any other reason, which the Investigator feels, would preclude safe inclusion of the subject.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method