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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list