Contact information
Type
Scientific
Primary contact
Prof B. Löwenberg
ORCID ID
Contact details
Erasmus Medical Centre
Daniel den Hoed Cancer Centre
Department of Hematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1598
b.lowenberg@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO29
Study information
Scientific title
Acronym
HOVON 29 AML/SAKK 30/95
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
CR rate.
Secondary outcome measures
1. Disease-free survival
2. Overall survival
Overall trial start date
30/03/1995
Overall trial end date
06/06/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1105
Participant 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
Recruitment start date
30/03/1995
Recruitment end date
06/06/2001
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3008 AE
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Sponsor details
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2693
hdc@hovon.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Amgen (The Netherlands)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Novartis (The Netherlands)
Alternative name(s)
Novartis AG, Novartis International AG
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Funder name
Pharma B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Roche Nederland B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johnson & Johnson (The Netherlands)
Alternative name(s)
Johnson & Johnson, J&J
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list