Randomised Prospective Comparison of the NMA Allograft and the Traditional Allograft in Acute Myeloid Leukaemia
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ClinicalTrials.gov Identifier: NCT00224614 |
Recruitment Status : Unknown
Verified June 2005 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting
First Posted : September 23, 2005
Last Update Posted : December 14, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia, Myeloid, Acute | Procedure: Allogenic transplantation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult |
Study Start Date : | July 2005 |
Study Completion Date : | July 2009 |

- 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
- 1- global survival, without relapse, and the various complications of the graft at 2 years 2- quality of life 3- the cost. 4- kinetics of the chimerism donor/receiver and his predictive value of the relapse and the reaction of the graft against the host.

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Ages Eligible for Study: | 35 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224614
Contact: CORDONNIER Catherine, Professor | +33 1 49 81 20 57 | carlcord@club-internet.fr |
France | |
Henri Mondor Hospital | Recruiting |
Créteil, Val de Marne, France, 94010 | |
Contact: CORDONNIER Catherine, professor +33 1 49 81 20 57 carlcord@club-internet.fr |
Principal Investigator: | CORDONNIER Catherine, Professor | Assistance Publique - Hôpitaux de Paris |
Publications:
ClinicalTrials.gov Identifier: | NCT00224614 |
Other Study ID Numbers: |
P040420 AOM04088 |
First Posted: | September 23, 2005 Key Record Dates |
Last Update Posted: | December 14, 2005 |
Last Verified: | June 2005 |
stem cell transplantation reduced-intensity conditioning regimen acute myeloid leukemia |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |