Imatinib in combination with cytarabine as compared to Imatinib alone in patients with first chronic phase chronic myeloid leukemia. A prospective randomized phase III study.

ISRCTN ISRCTN51564734
DOI https://doi.org/10.1186/ISRCTN51564734
Secondary identifying numbers HO78, NL615, NTR674
Submission date
07/06/2006
Registration date
07/06/2006
Last edited
08/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof J.J. Cornelissen
Scientific

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

Phone +31 (0)10 4391598 or +31 (0)10 4391367
Email j.cornelissen@erasmusmc.nl

Study information

Study designA prospective randomized, parallel group, phase III study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleImatinib in combination with cytarabine as compared to Imatinib alone in patients with first chronic phase chronic myeloid leukemia. A prospective randomized phase III study.
Study acronymHOVON 78 CML
Study objectivesThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic myeloid leukemia
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Imatinib, cytarabine
Primary outcome measureRate of major molecular response at 12 months from randomization
Secondary outcome measures1. 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 study start date08/05/2006
Completion date08/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants330
Total final enrolment109
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment08/05/2006
Date of final enrolment08/05/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

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

HOVON Data Center
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone +31 (0)10 4391568
Email hdc@erasmusmc.nl
ROR logo "ROR" https://ror.org/056kpdx27

Funders

Funder type

Industry

Roche Nederland BV

No information available

Dutch Cancer Society

No information available

Amgen
Government organisation / For-profit companies (industry)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Location
United States of America
Johnson and Johnson-Orthobiotech

No information available

Novartis Pharma B.V.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2013 08/01/2021 Yes No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.