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 |
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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
Contact information
Prof J.J. Cornelissen
Scientific
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 |
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j.cornelissen@erasmusmc.nl |
Study information
Study design | A prospective randomized, parallel group, phase III study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | 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. |
Study acronym | HOVON 78 CML |
Study objectives | The 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) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | 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 study start date | 08/05/2006 |
Completion date | 08/05/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | 330 |
Total final enrolment | 109 |
Key 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 |
Key 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 |
Date of first enrolment | 08/05/2006 |
Date of final enrolment | 08/05/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Sponsor information
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)
Research organisation
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 |
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hdc@erasmusmc.nl | |
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)
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 | |
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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 |
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.