Chronic myeloid leukemia.
Conditions
Interventions
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
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
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
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hematological and cytogenetical remission; 2. Overall survival; 3. Remission duration. | — |
Contacts
Public ContactJ.J. Cornelissen
Erasmus Medical Center, Daniel den Hoed Cancer Center, Department of Hematology, P.O. Box 5201
Outcome results
None listed