The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
First chronic phase Chronic Myeloid Leukemia
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Rate of major molecular response at 12 months from randomization.
Achtergrond van het onderzoek
- 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
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL615 |
| NTR-old | NTR674 |
| Ander register | : HO78 |
| ISRCTN | ISRCTN51564734 |