Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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

http://www.hovon.nl/

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

Publication citations

Additional files

Editorial Notes