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

Phase 2

Completed

• Conditions: Hematological Malignancies
• Interventions: Drug: Fludarabine, Busulfan, Thymoglobuline

• Registration Number: NCT00841724
• Lead Sponsor: Nantes University Hospital

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 so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Busilvex, Fludara, Thymoglobuline	Fludarabine, Busulfan, 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

Primary Outcome Measures

Name	Time	Method
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation	12 months after transplantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Bordeaux; 🇫🇷 Pessac, France