Risk adapted treatment of Acute Myelocytic Leukaemia (AML)
- Conditions
- Acute Myeloid Leukaemia (AML)Cancer
- Registration Number
- ISRCTN76815071
- Lead Sponsor
- Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1105
First randomisation:
1. Patients with newly diagnosed de novo Acute Myelocytic Leukaemia (AML) (including all cytological subtypes M0-M7)
2. Age 15 - 60 years inclusive
3. Patients have given informed consent
4. Leucocytosis (White Blood Cells [WBC] greater than 30 x 10^9/l) is not an exclusion criterion, but it will require postponement of Granulocyte-Colony Stimulating Factor (G-CSF) administration until WBC have declined to 20 x 10^9/l on chemotherapy
Patients after completion of CYCLE II and peripheral blood stem cell collection are eligible for second randomisation if:
1. Complete remission continues (marrow cytology and blood evaluation)
2. Poor risk status according to criteria of Appendix III
3. Not eligible for genotypically Human Leukocyte Antigen (HLA) matched allogeneic Bone Marrow Transplant (BMT)
4. Absence of congestive heart failure or pulmonary disease
5. Serum bilirubin as parameter of liver function abnormalities not elevated above 3 x normal value
6. Number of blood cells collected ('transplant'; PBSCT) being at least 2 x 10^8 nucleated cells/kg or 10 x 10^4 Colony-Forming Units Granulocyte-Macrophage (CFU-GM) per kg or 2 x 10^6 CD34-positive cells per kg. In case of no or insufficient PBSCT, an adequate autologous marrow graft must have been collected
7. Performance status of World Health Organization (WHO) grade 0, 1 or 2 at time of randomisation
8. Informed consent
First randomisation:
1. Patients with a concurrent active malignancy, except stage I cervix carcinoma and basocellular carcinoma
2. Patients previously treated with chemotherapy
3. Leukaemia following from a documented myelodysplasia with a duration of more than 6 months
4. Blastic crisis of chronic myeloid leukaemia or leukaemia developing from myeloproliferative diseases (e.g. polycythemia vera, myelofibrosis)
5. Renal or liver function abnormalities i.e. creatinine and bilirubin of more than 3 x normal value, except if directly attributable to the leukaemia (high serum lysosymes, hyperuricemia, leukaemic cell infiltration)
6. Human Immunodeficiency Virus (HIV) positive serology
7. Patients with severe cardiac, pulmonary or neurologic disease
8. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CR rate.
- Secondary Outcome Measures
Name Time Method 1. Disease-free survival<br>2. Overall survival