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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Clofarabine
CAS Number
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for the AML16 Pilot trial if: They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — 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 a presenting white count of less than 30x109 /l — 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: Patients are not eligible for the AML16 Pilot 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 have abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations. — Patients who have Acute Promyelocytic Leukaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of combining Daunorubicin and Clofarabine and Daunorubicin + Clofarabine with Mylotarg in the treatment of Acute Myeloid Leukaemia and high risk Myelodyspalstic Syndrome in older (>60 years) patients;Secondary Objective: Assess Disease response;Primary end point(s): NCI Toxicity Criteria | — |
Countries
United Kingdom
Outcome results
None listed