ITT 08-01: Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00841724

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

27.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancies	Drug: Fludarabine, Busulfan, Thymoglobuline	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Fludarabine, Busulfan, Thymoglobuline

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Fludarabine, Busulfan, Thymoglobuline

Outcome Measures

Primary Outcome Measures

Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation [12 months after transplantation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.