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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
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
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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 leukaemia (AML) of the adult for the patients of less than 55 years, because it offers chances of cure higher than chemotherapy or the auto-graft. However, mortality related to the traditional graft is approximately 30% to 1 year. The recent use of the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect rests exclusively on the allogenic effect "graft-versus-leukaemia" makes it possible to obtain among patients of more than 55 years in complete reemission (CR), survivals without relapses comparable with the traditional allograft among patients of more than 35 years. The major interest of NMA graft is to reduce early mortality related to the graft. This reduction should be all the more significant as the patient is younger, and thus bring to a better survival. There is not, at the present hour, of prospective comparative study of the two procedures of graft. Taking into account the results observed after NMA graft among patients of more than 55 years, and taking into account the toxicity of the standard graft between 35 and 55 years, it is essential to now compare the 2 approaches among patients who do not have a counter-indication for one or the other, in the age bracket where the toxicity of the traditional graft is highest.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Procedure: Allogenic transplantation Phase 3

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 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.
Study Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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


Contacts
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Contact: CORDONNIER Catherine, Professor +33 1 49 81 20 57 carlcord@club-internet.fr

Locations
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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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: CORDONNIER Catherine, Professor Assistance Publique - Hôpitaux de Paris
More Information
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Additional Information:

Publications:

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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
Keywords provided by Assistance Publique - Hôpitaux de Paris:
stem cell transplantation
reduced-intensity conditioning regimen
acute myeloid leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms