Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
NCT ID: NCT00841724
Last Updated: 2012-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2009-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Busilvex, Fludara, Thymoglobuline
D-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion
Fludarabine, Busulfan, Thymoglobuline
Interventions
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Fludarabine, Busulfan, Thymoglobuline
Eligibility Criteria
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Inclusion Criteria
* Adults (men or women) aged between 18 and 65 years
* Negative test for pregnancy
* ECOG 0-1 or Karnofsky Index ≥ 70%
* Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted)
* Life expectancy \> 6 months
* Signed informed consent
* Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation
Exclusion Criteria
* Classical contra-indications to the allogeneic stem cell transplantation procedure
* Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics
* Patients aged \< 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen
* An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection
* History of uncontrolled psychiatric condition
* Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.
18 Years
65 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Nantes University Hospital
Principal Investigators
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Mohamad Mohty, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Institut Paoli Calmettes
Marseille, , France
CHU de Nantes
Nantes, , France
CHU de Bordeaux
Pessac, , France
Countries
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Other Identifiers
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BRD 08/9-P
Identifier Type: -
Identifier Source: org_study_id
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