search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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.


- candidate number2080
- NTR NumberNTR674
- ISRCTNISRCTN51564734
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR4-mei-2006
- Secondary IDsHO78 
- Public 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.
- 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.
- ACRONYMHOVON 78 CML
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedChronic myeloid leukemia
- Inclusion criteria1. Newly diagnosed patients with CML in first chronic phase <= 2 months; 2. Presence of Philadelphia chromosome or bcr-abl rearrangement; 3. Age 18-65 years inclusive; 4. WHO performance status <= 2; 5. Written informed consent.
- Exclusion criteria1. CML in accelerated phase or blastic crisis as defined by the WHO criteria; 2. Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N, and/or ASAT >= 4 x N); 3. Renal dysfunction (creatinine >= 200 micromol/l or 2.3 mg/dl); 4. Severe cardiac dysfunction (NYHA classification II-IV); 5. Severe pulmonary or neurologic 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 HIV-positive; 9. Patients with active, uncontrolled infections; 10. Previous treatment other than hydroxyurea <= 2 months or imatinib <= 1 month; 11. Male and female patients of reproductive potential who are not practicing effective means of contraception.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 8-mei-2006
- planned closingdate8-mei-2011
- Target number of participants330
- InterventionsPatients meeting all eligibility criteria will be randomized between: Arm A: imatinib given orally at a total dose of 800 mg daily until progression; OR Arm B: imatinib given orally at a total dose of 800 mg daily, combined with 2 successive cycles of 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.
- Primary outcomeRate of major molecular response at 12 months from randomization.
- Secondary outcome1. 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.
- Timepoints
- Trial web sitehttp://www.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.J. Cornelissen
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J. Cornelissen
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Roche Nederland BV, Novartis Pharma B.V., Johnson&Johnson-Orthobiotech
- PublicationsN/A
- Brief summary- Study phase: Phase III - Study objectives: To determine the efficacy of the combination of imatinib with cytarabine as compared to imatinib alone in terms of the rate of molecular response at 12 months from randomization. - Patient population: Patients with Chronic Myeloid Leukemia, Philadelphia-positive (cytogenetics) or bcr-abl positive (PCR), in first chronic phase <= 2 months from diagnosis, age 18-65 years inclusive - Study design: Prospective, multicenter, randomized - Duration of treatment: Until progression
- Main changes (audit trail)
- RECORD4-mei-2006 - 3-jul-2006


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl