Condition category
Cancer
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
08/06/2006
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

Prof J.J. Cornelissen

ORCID ID

Contact details

Erasmus Medical Center
Daniel den Hoed Cancer Center
Department of Hematology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391598 or +31 (0)10 4391367
j.cornelissen@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HO78

Study information

Scientific title

Acronym

HOVON 78 CML

Study hypothesis

The hypothesis to be tested is that the outcome in arm B is better than in arm A.

Ethics approval

Not provided at time of registration

Study design

A prospective randomized, parallel group, phase III study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic myeloid leukemia

Intervention

Patients meeting all eligibility criteria will be randomized between:
Arm A: imatinib given orally at a total dose of 800 mg daily until progression
Arm B: imatinib given orally at a total dose of 800 mg daily, combined with 2 successive cycles of intravenous ( i.v.) cytarabine 200 mg/m^2, at day 1-7, in cycles I and II, followed by imatinib monotherapy (800 mg daily) until progression

Intervention type

Drug

Phase

Phase III

Drug names

Imatinib, cytarabine

Primary outcome measures

Rate of major molecular response at 12 months from randomization

Secondary outcome measures

1. Rate and duration of major and complete molecular response
2. Rate and duration of major and complete cytogenetic response
3. Rate and duration of complete hematological response
4. Progression-free survival (i.e. time from registration to progression or death from any cause, whichever occurs first)
5. Overall survival measured from the time of registration. Patients still alive or lost to follow-up are censored at the date they were last known to be alive.
6. Toxicity
7. Actual dose-intensity of imatinib delivered
8. Incidence of mutations of abl-kinase domain

Overall trial start date

08/05/2006

Overall trial end date

08/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Newly diagnosed patients with chronic myeloid leukemia (CML) in first chronic phase </= 2 months
2. Presence of Philadelphia chromosome or bcr-abl rearrangement
3. Age 18-65 years inclusive
4. World Health Organization (WHO) performance status </= 2
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

330

Participant exclusion criteria

1. CML in accelerated phase or blastic crisis as defined by the WHO criteria
2. Hepatic dysfunction (serum bilirubin >/= 2 x upper limit of normal [ULN], and/or alanine aminotransferase [ALAT] >/= 4 x ULN, and/or aspartate aminotransferase [ASAT >/= 4 x ULN)
3. Renal dysfunction (creatinine >/= 200 µmol/l or 2.3 mg/dl)
4. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II-IV)
5. Severe pulmonary or neurological disease
6. Pregnant or lactating females
7. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
8. Patients known to be human immunodeficiency virus (HIV)-positive
9. Patients with active, uncontrolled infections
10. Previous treatment other than hydroxyurea for </= 2 months or imatinib for </= 1 month
11. Male and female patients of reproductive potential who are not practicing effective means of contraceptio

Recruitment start date

08/05/2006

Recruitment end date

08/05/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)

Sponsor details

HOVON Data Center
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391568
hdc@erasmusmc.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Roche Nederland BV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Cancer Society

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Amgen

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

Johnson and Johnson-Orthobiotech

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis Pharma B.V.

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