Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome MedDRA version: 7.1 Level: LLT Classification code 10000880
Conditions
Interventions
Trade Name: Clofarabine
Product Name: Clofarabine
Product Code: Clofarabine
Pharmaceutical Form: Solution for infusion
Concentration uni
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Patients are eligible for the AML16 trial if: They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification — this can be any type of de novo or secondary AML – or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2) — They should normally be over the age of 60, but patients under this age are eligible if they are not considered fit for the MRC AML 15 trial. — They have given written informed consent. 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
Exclusion criteria: Exclusion criteria Patients are not eligible for the AML15 trial if: — They have previously received cytotoxic chemotherapy for AML. [Hydroxyurea, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.] — They are in blast transformation of chronic myeloid leukaemia (CML). They have a concurrent active malignancy. — They are pregnant or lactating. — Patients with abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations. — Patients with Acute Promyelocytic Leukaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Questions for patients considered fit for intensive treatment: — compare induction schedules (DA and DClo). — assess the value of Mylotarg in induction in combination with DA or DClo in course 1. — — To compare two versus three courses of induction/consolidation treatment — To compare the use of Demethylation maintenance treatment with Azacitidine with no maintenance — Assess the value of Reduced Intensity Allogeneic Stem Cell Transplantation Questions for patients not considered fit for intensive treatment: To compare Low Dose Ara-C versus available novel approaches: — Low Dose Ara-C with Mylotarg — Low Dose Ara-C with Zarnestra — Low Dose Clofarabine During the course of the Programme other novel therapies are expected to become available, and will be considered for inclusion in this comparison ; Secondary Objective: — The relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission. — The relevance of the molecular detection of FLT3 and RAS mutation, and resistance protein status to response to treatment. — Evaluation of methods of minimal residual disease monitoring. — To assess gene methylation status in relationship to treatment with maintenance Azacytidine. — To store excess diagnostic tissue for future research in the AML Cell Bank. ; Primary end point(s): Endpoints The main endpoints for the therapeutic questions in patients considered fit for intensive treatment for each comparison will be: — Complete remission (CR) achievement and reasons for failure (for induction questions). — Duration of remission, relapse rates and deaths i | — |
Countries
Denmark, United Kingdom
Outcome results
None listed