Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation - CML DASATINIB

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1) Male or female patients minimum 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 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.

10) Negative pregnancy test for women of child bearing age

11) The need to be affiliated with (NATIONAL) health insurance or beneficiary of such a regime.

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

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 (list of prohibited therapies can be found in section 8.6.1)

5) Patients previously treated with Dasatinib.

6) Absence of written informed consent.

7)Patients incapable of giving consent personally.

8) Presence of serious concomitant disease.

9) History of a significant bleeding disorder unrelated to CML.

10) Pregnancy or lactation status positive.

11) Patients and/or female partners of male patients not using highly effective method of birth control i.e. intrauterine device (IUD), hormonal (oral pill, injection, implants), tubal ligation or partner’s vasectomy

12)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.

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

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

15)Concomitant Medications, any of the following should be considered for exclusion:
a)Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting Dasatinib):
i)quinidine, procainamide, disopyramide.
ii)amiodarone, sotalol, ibutilide, dofetilide.
iii)erythromycin, clarithromycin.
iv)chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone.
v)cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
b)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.

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

Related Trials