|- candidate number||1488|
|- NTR Number||NTR290|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||Ho38 |
|- Public Title||High-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia.|
|- Scientific Title||High-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia.|
|- ACRONYM||HOVON 38 CML|
|- hypothesis||The hypothesis to be tested is that the outcome in arm A is better than in arm B.|
|- Healt Condition(s) or Problem(s) studied||Chronic Myeloid Leukemia (CML)|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-jan-1998|
|- planned closingdate||15-jun-2001|
|- Target number of participants||102|
|- 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:
Cycle I: cytarabin/idarubicin
Cycle II: high-dose cytarabin
Maintenance with Interferon-alpha-2a
Low-dose cytarabin + interferon-alpha-2a
Maintenance with interferon-alpha-2a.
|- Primary outcome||Event-free survival.|
|- Secondary outcome||1. Hematological and cytogenetical remission;|
2. Overall survival;
3. Remission duration.
|- Trial web site||http://www.hovon.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.J. Cornelissen|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.J. Cornelissen|
|- Sponsor/Initiator ||VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Erasmus Medical Center, Daniel den Hoed Cancer Center |
(Source(s) of Monetary or Material Support)
|Amgen, CKTO, Johnson & Johnson, Roche Nederland BV, Novartis Pharma B.V.|
|- Publications||Ann Hematol. 2007 Feb;86(2):117-25. Epub 2006 Oct 10.|
|- Brief summary||Study phase: phase III;|
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.
patients with newly diagnosed CML in first chronic phase <= 6 months with Ph chromosome or BCL/ABR, age 16-60 yrs inclusive.
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.
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 28-aug-2008|