Overview

Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
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 so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nantes University Hospital
Treatments:
Busulfan
Fludarabine
Thymoglobulin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.