Status:
COMPLETED
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Lead Sponsor:
Nantes University Hospital
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a s...
Eligibility Criteria
Inclusion
- Patients affiliated to a social security reimbursement system
- 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
- Pregnant woman or not willing to take effective contraception
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00841724
Start Date
January 1 2009
End Date
January 1 2012
Last Update
May 16 2012
Active Locations (3)
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1
Institut Paoli Calmettes
Marseille, France, 13273
2
CHU de Nantes
Nantes, France, 44093
3
CHU de Bordeaux
Pessac, France, 33604