No registrations found.
ID
Source
Brief title
Health condition
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
Event-free survival.
Secondary outcome
1. Hematological and cytogenetical remission;
2. Overall survival;
3. Remission duration.
Background summary
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.
Study objective
The hypothesis to be tested is that the outcome in arm A is better than in arm B.
Study design
N/A
Intervention
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.
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 <= 6 months;
2. Presence of Philadelphia chromosome or BCR/ABL rearrangement;
3. Age 16-65 years inclusive;
4. WHO performance scale <= 2.
Exclusion criteria
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.
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 | NL252 |
| NTR-old | NTR290 |
| Other | : Ho38 |
| ISRCTN | ISRCTN84226319 |