Efficacy and Safety Study of Dasatinib in Patients With Chronic Myeloid Leukemia

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment, such as imatinib therapy.

A relapse is when an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again.

A total of 50 patients ≥18 years of age will be registered on the trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Group for Blood and Marrow Transplantation; European Society for Blood and Marrow Transplantation
• Collaborator: Bristol-Myers Squibb
• Treatments: Dasatinib

Criteria

Inclusion Criteria:

1. Male or female patients greater or equal to 18 years of age.

2. Diagnosed with BCR-ABL (+) Chronic Myeloid Leukemia (they can be Philadelphia chromosome positive or negative)

3. Prior therapy including imatinib

4. Patients transplanted from an HLA-identical sibling or an HLA-matched unrelated donor.

5. Patients transplanted in first chronic phase or accelerated phase.

6. Patients with untreated relapse of BCR-ABL (+) CML (they can be Philadelphia chromosome positive or negative) after allogeneic transplantation and entered within 6 weeks of the first detection of relapse.

7. Molecular, cytogenetic or haematological relapse in chronic or accelerated phase.

8. Written informed consent.

9. Absence of serious concomitant illness

Exclusion Criteria:

1. Patients relapsing in blast crisis.

2. Patients transplanted after blastic transformation of CML.

3. Patients receiving any therapy for relapse other than withdrawal of immunosuppression (DLI is not permitted).

4. Patients treated with other investigational agents during the previous 30 days

5. Patients previously treated with Dasatinib.

6. Absence of written informed consent.

7. Presence of serious concomitant disease.

8. History of a significant bleeding disorder unrelated to CML.

9. Pregnancy or lactation status positive.

10. SGOT and SGPT more than 2.5 x the upper limit of the normal range as determined by the laboratory where the analysis is performed.

11. Total serum bilirubin level more than 2 x the upper limit of the normal range of the laboratory where the analysis is performed.

12. Serum creatinine concentration more than 1.5 x the upper limit of the normal range of the laboratory where the analysis is performed.

13. Concomitant Medications, any of the following should be considered for exclusion:

• Category I drugs that are generally accepted to have a risk of causing Torsades de Points including: (Patients must discontinue drug 7 days prior to starting Dasatinib):

• quinidine, procainamide, disopyramide.

• amiodarone, sotalol, ibutilide, dofetilide.

• erythromycin, clarithromycin.

• chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone.

• cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.

• The concomitant use of H2 blockers or proton pump inhibitors with Dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving Dasatinib therapy. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of Dasatinib.