Contact information
Type
Scientific
Primary contact
Dr J.J. Cornelissen
ORCID ID
Contact details
Erasmus Medical Centre
Daniel den Hoed Cancer Centre
Department of Haematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 439 1598
j.cornelissen@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR290; Ho38
Study information
Scientific title
Acronym
HOVON 38 CML
Study hypothesis
The hypothesis to be tested is that the outcome in arm A is better than in arm B
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
Chronic myeloid leukemia (CML)
Intervention
Induction therapy with hydroxyurea (3 - 4 weeks). Patients less than or equal to 55 years with a HLA identical sibling proceed to allo-BMT. All other patients are randomised between:
Arm A: Cycle I: cytarabin/idarubicin, Cycle II: high-dose cytarabin; maintenance with interferon-alpha-2a
Arm B: Low-dose cytarabin and interferon-alpha-2a; maintenance with interferon-alpha-2a
Intervention type
Drug
Phase
Phase III
Drug names
Cytarabin, idarubicin, interferon-alpha-2a, hydroxyurea
Primary outcome measures
Event-free survival
Secondary outcome measures
1. Haematological and cytogenetical remission
2. Overall survival
3. Remission duration
Overall trial start date
23/01/1998
Overall trial end date
15/06/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Newly diagnosed patients with chronic myeloid leukemia (CML) in first chronic phase less than or equal to 6 months
2. Presence of Philadelphia chromosome or BCR/ABL rearrangement
3. Age 16 - 65 years inclusive
4. World Health Organisation (WHO) performance scale less than or equal to 2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
102
Participant exclusion criteria
1. CML in blastic phase
2. CML in accelerated phase
3. Hepatic dysfunction (bilirubin greater than or equal to 2 x normal, and/or alanine aminotransferase [ALAT] greater than 4 x normal)
4. Renal dysfunction (creatinine greater 200 mumol/l or 23 mg/dl)
5. Patients with severe cardiac, pulmonary or neurologic disease
6. Pregnant or lactating females
7. Human immunodeficiency virus (HIV) infection
8. Other malignancies, except stage I cervix carcinoma and basocellular carcinoma
Recruitment start date
23/01/1998
Recruitment end date
15/06/2001
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
Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johnson & Johnson (Netherlands)
Alternative name(s)
Johnson & Johnson, JNJ
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Funder name
Amgen (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
Roche Nederland BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novartis Pharma BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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