Status:
UNKNOWN
Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
35-55 years
Phase:
PHASE3
Brief Summary
The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is recognized acute myeloid l...
Detailed Description
Will not be included in CR1 nor the patients with good forecast under chemotherapy, (Inv 16; t(8;21)), nor patients at the very high risk of relapse (anomalies complex cytogenetics). The conditioning ...
Eligibility Criteria
Inclusion
- Age: from 35 to 55 years completed
- de novo Acute Myeloid Leukaemia (AML) in Complete remission (CR)1, requiring an allograft according to the therapeutic protocol in which (or according to which) the patient is treated or secondary AML with a myelodysplasy or a chemotherapy in CR1 or de novo AML or secondary to a myelodysplasy or a chemotherapy, in CR2.
- having an géno-identical fraternal donor
- having received, since obtaining the remission (1 or 2) a consolidation comprising at least 6 bolus of Aracytine (\> 500 mg/m2 for each amount) and at least 1 day of anthracycline to the usual amounts (Idarubicin: 12 mg/m2 or Daunorubicin 50 to 80 mg/m2)
- Signed assent of receiver
- Signed assent of the donor
Exclusion
- If CR1: AML with T 8,21 or inv 16 or LAM3, or AML with complex anomalies cytogenetics (= 5 anomalies without relation between them)
- If CR2: duration of CR1 \< 4 months
- Acute transformation of a myeloproliferative syndrome
- Former autograft or allogreffe
- Karnofsky \< 50%
- Clearance of creatinin \< 40 ml/min
- Transaminases \> 8 N
- Any situation contra-indicating a traditional conditioning of allograft, in particular: serious cardiopathy, chronic respiratory insufficiency cutting down the pulmonary functions by at least 30%, fibrose hepatic.
- Donor having a counter-indication with the administration of growth promoters or a general anaesthesia.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00224614
Start Date
July 1 2005
End Date
July 1 2009
Last Update
December 14 2005
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, Val de Marne, France, 94010