The hypothesis to be tested is that the outcome in arm A is better than in arm B.
ID
Bron
Verkorte titel
Aandoening
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
Event-free survival.
Achtergrond van het onderzoek
Study phase: phase III;
Study objective:
Evaluation of the effect of high-dose cytarabin compared to low-dose cytarabin combined with IFN-alpha-2a preceding IFN-alpha-2a maintenance on mentioned endpoints. Evaluation of endpoints after Allo BMT and comparison with arm A and arm B.
Patient population:
patients with newly diagnosed CML in first chronic phase <= 6 months with Ph chromosome or BCL/ABR, age 16-60 yrs inclusive.
Study design:
prospective, multicenter, randomized.
Duration of treatment:
Hydroxyurea treatment lasts about 4 weeks, duration of treatment in arm A is about 1-2 months, in arm B maximally 2 years. IFN-alpha-2a maintenance is continued for as long as possible.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm A is better than in arm B.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Induction therapy with Hydroxyurea (3-4 weeks).
Patients <= 55 yrs with a HLA identical sibling proceed to Allo BMT. All other patients are randomized between:
Arm A:
Cycle I: cytarabin/idarubicin
Cycle II: high-dose cytarabin
Maintenance with Interferon-alpha-2a
Arm B:
Low-dose cytarabin + interferon-alpha-2a
Maintenance with interferon-alpha-2a.
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 <= 6 months;
2. Presence of Philadelphia chromosome or BCR/ABL rearrangement;
3. Age 16-65 years inclusive;
4. WHO performance scale <= 2.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. CML in blastic phase;
2. CML in accelerated phase;
3. Hepatic dysfunction (bilirubin >= 2 N, and/or ALAT > 4 N);
4. Renal dysfunction (creatinine > 200 mumol/l or 2.3 mg/dl);
5. Patients with severe cardiac, pulmonary or neurologic disease;
6. Pregnant or lactating females;
7. HIV infection;
8. Other malignancies, except stage I cervix carcinoma and basocellular carcinoma.
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 | NL252 |
| NTR-old | NTR290 |
| Ander register | : Ho38 |
| ISRCTN | ISRCTN84226319 |