The Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder
Randomized, Open Label Study of Dasatinib (100mg qd) vs. High-Dose Imatinib (600mg) in Patients With Chronic Phase CML Who Have Had Suboptimal Response After 3-18 Months of Therapy With Imatinib (400mg)
2 other identifiers
expanded_access
N/A
0 countries
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Brief Summary
Research Hypothesis: Treatment with dasatinib 100 mg QD is superior to imatinib 600 mg QD in terms of complete cytogenetic response (CCyR) in chronic phase (CP) Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukemia (CML) subjects who are imatinib failures or who have achieved only a suboptimal response after 3-18 months (12-77 weeks) of therapy with imatinib 400 mg. Primary Objective: The primary objective of this study is to compare the rate of CCyR of dasatinib (100mg QD) to high-dose imatinib (600 mg QD) therapy at 6 months after randomization in CP Ph+ CML subjects who are imatinib failures or who have achieved only a suboptimal response after 3 - 18 months of imatinib monotherapy at 400 mg/day.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedMarch 3, 2009
March 1, 2009
March 2, 2009
March 2, 2009
Conditions
Keywords
Interventions
Dasatinib Dasatinib will be administered orally at a dose of 100 mg QD. During the first month, subjects will be instructed to take dasatinib in the morning. Imatinib Imatinib will be administered orally at a dose of 600 mg once daily (QD). Each 600 mg dose should be administered with a meal and taken with a large glass of water. If a scheduled dose is missed for more than 12 hours or dosing is interrupted for toxicity or for any other reason, these doses should be omitted.
Eligibility Criteria
You may qualify if:
- Signed written informed consent, at least 18 years old
- Adequate hepatic renal function
- Dasatinib naïve patients
- Patients with cytogenetically and/or molecularly confirmed Philadelphia chromosome or BCR-ABL positive CP-CML who have been treated with standard dose of imatinib.
- ECOG status: 0-2
- And one of following criteria for imatinib suboptimal response 1)CP-CML patients who have failed to achieve a CHR at 3 months or MCyR at 6 months of therapy with imatinib 400mg daily. 2)CP-CML patients who have failed to achieve a CCyR at 12 months with imatinib 400mg daily 3)CP-CML patients who have failed to achieve a MMoR (less than 3 log reduction) at 18 months with imatinib 400mg daily 4)CP-CML patients who have lost molecular response by an increase of BCR-ABL more than 10 times regardless treatment duration.
You may not qualify if:
- Concurrent malignancy
- Patients who have received SCT
- Allergy or hypersensitivity reaction to the study drugs
- Female who are pregnant or breast feeding.
- T315I mutation
- History of significant bleeding disorder
- Women of child bearing potential
- Uncontrolled or significant CVS disease: IHD. CHF
- Prior imatinib\>400mg, imatinib\>18 months
- Intolerance to imatinib 400mg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jooseop Chung, MD. PhD
Pusan National University Hospital, Korea
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 2, 2009
First Posted
March 3, 2009
Last Updated
March 3, 2009
Record last verified: 2009-03