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Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult


Phase 3
35 Years
55 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

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Trial Information

Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult


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 of MA graft will be Cyclophosphamide and ICT with strong amounts. NMA graft
will be made according to the protocol Seattle (fludarabine 30 mg/m2/j X 3 and ICT of 2 Gy).
The study will be undertaken in 12 French centers of allograft taking part in the protocols
ESPARTO or EORTC.


Inclusion Criteria:



1. Age: from 35 to 55 years completed

2. 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.

3. having an géno-identical fraternal donor

4. 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)

5. Signed assent of receiver

6. Signed assent of the donor

Exclusion Criteria:

1. If CR1: AML with T 8,21 or inv 16 or LAM3, or AML with complex anomalies
cytogenetics (= 5 anomalies without relation between them)

2. If CR2: duration of CR1 < 4 months

3. Acute transformation of a myeloproliferative syndrome

4. Former autograft or allogreffe

5. Karnofsky < 50%

6. Clearance of creatinin < 40 ml/min

7. Transaminases > 8 N

8. 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.

9. Donor having a counter-indication with the administration of growth promoters or a
general anaesthesia.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To show that NMA graft reduces mortality related to the procedure to 10%, compared to 30% waited in the arm of reference (α : 5%; p: 80%; bilateral formulation), 50 patients will be included in each arm

Principal Investigator

CORDONNIER Catherine, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

AP-HP

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

P040420

NCT ID:

NCT00224614

Start Date:

July 2005

Completion Date:

July 2009

Related Keywords:

  • Leukemia, Myeloid, Acute
  • stem cell transplantation
  • reduced-intensity conditioning regimen
  • acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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