The Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder

• Status: Available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

Details

• Lead Sponsor: Pusan National University Hospital
• Treatments: Dasatinib; Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Signed written informed consent, at least 18 years old

2. Adequate hepatic renal function

3. Dasatinib naïve patients

4. Patients with cytogenetically and/or molecularly confirmed Philadelphia chromosome or BCR-ABL positive CP-CML who have been treated with standard dose of imatinib.

5. ECOG status: 0-2

6. 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.

Exclusion Criteria:

1. Concurrent malignancy

2. Patients who have received SCT

3. Allergy or hypersensitivity reaction to the study drugs

4. Female who are pregnant or breast feeding.

5. T315I mutation

6. History of significant bleeding disorder

7. Women of child bearing potential

8. Uncontrolled or significant CVS disease: IHD. CHF

9. Prior imatinib>400mg, imatinib>18 months

10. Intolerance to imatinib 400mg