Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
23/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.hovon.nl/

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

corporate

Location

United States of America

Funder name

Novartis (The Netherlands)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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, JNJ

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes