High-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia

ISRCTN	ISRCTN84226319
DOI	https://doi.org/10.1186/ISRCTN84226319
Secondary identifying numbers	NTR290; Ho38

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

Dr J.J. Cornelissen
Scientific

Erasmus Medical Centre
Daniel den Hoed Cancer Centre
Department of Haematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone	+31 (0)10 439 1598
Email	j.cornelissen@erasmusmc.nl

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 38 CML
Study objectives	The hypothesis to be tested is that the outcome in arm A is better than in arm B
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Cytarabin, idarubicin, interferon-alpha-2a, hydroxyurea
Primary outcome measure	Event-free survival
Secondary outcome measures	1. Haematological and cytogenetical remission 2. Overall survival 3. Remission duration
Overall study start date	23/01/1998
Completion date	15/06/2001

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	102
Key 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
Key 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
Date of first enrolment	23/01/1998
Date of final enrolment	15/06/2001

Erasmus Medical Centre

Rotterdam
3008 AE
Netherlands

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

Industry

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

No information available

Johnson & Johnson (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

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

Roche Nederland BV (Netherlands)

No information available

Novartis Pharma BV (Netherlands)

No information available

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