Status:
COMPLETED
Randomized Study Comparing the Effect of Dasatinib and Imatinib on Malignant Stem Cells in Chronic Myeloid Leukemia
Lead Sponsor:
Norwegian University of Science and Technology
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis...
Detailed Description
An Open-Label, Randomized, Multicenter Phase II Trial Comparing the depletion of malignant stem cells with Dasatinib vs. Imatinib in Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemi...
Eligibility Criteria
Inclusion
- Patients are able to provide written informed consent
- Patients must have CML in CP which is defined by the presence of all of the following criteria:
- \< 15% blasts in peripheral blood (PB) and BM.
- \< 30% blasts plus promyelocytes in PB and BM.
- \< 20% basophils in the PB.
- ≥ 100 x 109/L platelets.
- No evidence of extramedullary leukemia apart from hepatosplenomegaly
- Ph+ or variants must be demonstrated by BM cytogenetics, FISH or PCR.
- Previously untreated CML in CP, with the exception of hydroxyurea or anagrelide
- Patients must be enrolled in this study within 90 days after the date of first being diagnosed with CML
- ECOG Performance Status (PS) Score 0 - 1 (see Appendix 2)
- Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional upper limit of normal (ULN) in absence of Gilbert type unconjugated hyperbilirubinemia; alanine aminotransferase (ALAT≤ 2.5 times the institutional ULN.
- Adequate renal function defined as serum creatinine ≤ 2 times the institutional ULN.
- Men and women, ages 18 years and older.
- Adequate BM aspiration sample before the start of study treatment (i.e sample is sufficient for stem cell analysis)
- Potentially fertile women must use an adequate method of contraception to avoid pregnancy throughout the study.
- Potentially fertile women must have a negative serum or urine pregnancy test
Exclusion
- Fertile women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
- Women who are pregnant or breastfeeding.
- Men with fertile sexual partners who can or will not use an acceptable contraception method for the entire study
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- Known pleural effusion at baseline.
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML, including:
- Prior chemotherapy for peripheral stem cell mobilization.
- Inadequate BM aspiration sample due to marrow fibrosis or other reasons
- Prior or concurrent malignancy
- Severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent
- Abuse of alcohol, prescribed or illicit drugs
- Evidence of digestive dysfunction that would prevent administration of study therapy by mouth.
- Prohibited Treatments and/or Therapies
- Any prior treatment with interferon
- Any prior treatment with dasatinib
- Any prior treatment with imatinib
- Any other prior systemic treatments, with anti-CML activity \[except for anagrelide, or hydroxyurea (HU)\].
- Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes as described in Appendix 3.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00852566
Start Date
March 1 2009
End Date
December 1 2015
Last Update
September 25 2017
Active Locations (7)
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1
Helsinki University Central Hospital
Helsinki, Finland, 00029
2
Bergen University Central Hospital
Bergen, Norway
3
Rikshospitalet
Oslo, Norway, 0027
4
St. Olavs Hospital
Trondheim, Norway, 7006