Risk adapted treatment of Acute Myelocytic Leukaemia (AML)

ISRCTN	ISRCTN76815071
DOI	https://doi.org/10.1186/ISRCTN76815071
Secondary identifying numbers	HO29

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

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
Email	b.lowenberg@erasmusmc.nl

Study information

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	CR rate.
Secondary outcome measures	1. Disease-free survival 2. Overall survival
Overall study start date	30/03/1995
Completion date	06/06/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Sponsor information

Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation

Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 2693
Email	hdc@hovon.nl
Website	http://www.hovon.nl/
"ROR"	https://ror.org/056kpdx27

Funders

Funder type

Industry

Amgen (The Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Amgen Inc., Applied Molecular Genetics Inc.
Location: United States of America

Novartis (The Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Novartis AG, Novartis International AG
Location: Switzerland

Pharma B.V. (The Netherlands)

No information available

Roche Nederland B.V. (The Netherlands)

No information available

Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)

No information available

Johnson & Johnson (The Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan