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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematological Malignancies

Intervention / Treatment
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* Drug: Fludarabine, Busulfan, Thymoglobuline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Busilvex, Fludara, Thymoglobuline<br>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 | Drug: Fludarabine, Busulfan, Thymoglobuline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation |  | 12 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the classical criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival |  | 12 months after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic stem cell transplantation, Reduced-intensity conditioning, Reduced-toxicity conditioning, Hematological malignancies, IV Busulfan