No registrations found.
ID
Source
Brief title
Health condition
First chronic phase Chronic Myeloid Leukemia
Sponsors and support
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Intervention
Outcome measures
Primary outcome
Rate of major molecular response at 12 months from randomization.
Secondary outcome
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.
Background 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
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
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;
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.
P.O. Box 5201
J.J. Cornelissen
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598 or +31 (0)10 4391367
j.cornelissen@erasmusmc.nl
P.O. Box 5201
J.J. Cornelissen
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391598 or +31 (0)10 4391367
j.cornelissen@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL615 |
| NTR-old | NTR674 |
| Other | : HO78 |
| ISRCTN | ISRCTN51564734 |