A phase II trial of high dose cytarabine and fludarabine without anthracycline for patients with core binding factor acute myeloid leukaemia, measuring efficacy, safety and monitoring minimal residual disease
- Conditions
- Core binding factor acute myeloid leukaemiaCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12605000152628
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 53
1. A morphologic diagnosis of AML by WHO criteria; note that patients with t(8;21) and less than 20% blasts will be included.2. Confirmation of CBF subtype by cytogenetic finding of t(8;21) or inv(16) or t(16;16) (either alone or in combination with other cytogenetic abnormalities) or PCR evidence of a CBF fusion transcript 3. ECOG performance status 0 to 3; 4. Written informed consent prior to registration 5. Potentially childbearing patients must use effective contraception 6. Patients must be registered prior to the commencement of induction therapy.
1. Serious cardiac or pulmonary dysfunction precluding the delivery of the proposed therapy2. Severe renal dysfunction3. Severe hepatic dysfunction including bilirubin > 2.5 ULN unless attributable to leukaemia4. Prior treatment for AML5. Contraindication to the use of study drugs6. Known HIV infection7. Pregnancy and lactation8. Inability to comply with study requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the failure-free (FFS) rates of patients with newly diagnosed core binding factor (CBF) acute myeloid leukaemia (AML) treated with high-dose cytarabine (Ara-C) containing regimens exclusive of anthracyclines.[ The first analysis of FFS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years from the attainment of a complete response (CR).];To establish the overall survival (OS) rates of patients with newly diagnosed core binding factor (CBF) acute myeloid leukaemia (AML) treated with high-dose cytarabine (Ara-C) containing regimens exclusive of anthracyclines.[ The first analysis of OS will take place 12 months after the last-registered patient has commenced treatment. If appropriate, the final analysis will take place after all patients have had a minimum potential follow-up of 4 years from the attainment of a complete response (CR).]
- Secondary Outcome Measures
Name Time Method