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High-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia.


- candidate number1488
- NTR NumberNTR290
- ISRCTNISRCTN84226319
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsHo38 
- Public TitleHigh-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia.
- Scientific TitleHigh-dose cytarabin versus low-dose cytarabin plus interferon-alpha-2a both followed by maintenance with interferon-alpha-2a in chronic myeloid leukemia.
- ACRONYMHOVON 38 CML
- hypothesisThe hypothesis to be tested is that the outcome in arm A is better than in arm B.
- Healt Condition(s) or Problem(s) studiedChronic Myeloid Leukemia (CML)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jan-1998
- planned closingdate15-jun-2001
- Target number of participants102
- InterventionsInduction 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.
- Primary outcomeEvent-free survival.
- Secondary outcome1. Hematological and cytogenetical remission;
2. Overall survival;
3. Remission duration.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.J. Cornelissen
- CONTACT for SCIENTIFIC QUERIESProf. 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
- Funding
(Source(s) of Monetary or Material Support)
Amgen, CKTO, Johnson & Johnson, Roche Nederland BV, Novartis Pharma B.V.
- PublicationsAnn Hematol. 2007 Feb;86(2):117-25. Epub 2006 Oct 10.
- Brief summaryStudy 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.
- Main changes (audit trail)
- RECORD9-sep-2005 - 28-aug-2008


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