Risk adapted treatment of Acute Myelocytic Leukaemia (AML)
| ISRCTN | ISRCTN76815071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76815071 |
| Protocol serial number | HO29 |
| Sponsor | Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands) |
| Funders | Amgen (The Netherlands), Novartis (The Netherlands), Pharma B.V. (The Netherlands), Roche Nederland B.V. (The Netherlands), Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands), Johnson & Johnson (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 23/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof B. Löwenberg
Scientific
Scientific
Erasmus Medical Centre
Daniel den Hoed Cancer Centre
Department of Hematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 439 1598 |
|---|---|
| b.lowenberg@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HOVON 29 AML/SAKK 30/95 |
| Study objectives | The hypotheses to be tested are that: 1. The outcome in arm B is better than in arm A 2. Following Peripheral Blood Stem Cell Transplant (PBSCT) is better than following Cycle III chemotherapy |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute Myeloid Leukaemia (AML) |
| Intervention | Patients (except AML-M3 or t[15;17]) will be randomised on entry between: Arm A: Cycle I: idarubicin + cytarabin Cycle II: amsacrin + cytarabin Arm B: Cycle I: idarubicin + cytarabin + G-CSF Cycle II: amsacrin + cytarabin + G-CSF Patients with AML-M3 or t(15;17) will receive arm A treatment. Patients in Complete Remission (CR) with good risk will proceed to cycle III: Mitoxantrone + VP-16. Patients in CR with poor risk and a HLA matched donor will proceed to Allo BMT. Patients in CR with poor risk without a HLA matched donor will be randomised between cycle III chemotherapy and Busulfan/Cyclophosphamide marrow ablative treatment and PBSCT. |
| Intervention type | Other |
| Primary outcome measure(s) |
CR rate. |
| Key secondary outcome measure(s) |
1. Disease-free survival |
| Completion date | 06/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1105 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 30/03/1995 |
| Date of final enrolment | 06/06/2001 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
