None listed
Conditions
Brief summary
This trial is assessing the outcome of patients with a rare form of AML (CBF-AML) who have anthracyline (or not) as part of their treatment
Interventions
Patients with CBF leukaemia will be treated with high dose Cytarabine and Fludarabine chemotherapy. An induction course will be followed by 6 consolidation cycles 3 of which are Cytarabine alone and 3 of which are fludarabine & cytarabine in combination but in lower total doses than in the induction cycle. Total treatment time will be 7 to 9 months. In addition, minimal residual disease will be monitored using sensitive laboratory methods at 1 and 3 monthly intervals for blood and bone marrow re
Patients with CBF leukaemia will be treated with high dose Cytarabine and Fludarabine chemotherapy. An induction course will be followed by 6 consolidation cycles 3 of which are Cytarabine alone and 3 of which are fludarabine & cytarabine in combination but in lower total doses than in the induction cycle. Total treatment time will be 7 to 9 months. In addition, minimal residual disease will be monitored using sensitive laboratory methods at 1 and 3 monthly intervals for blood and bone marrow respectively.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed