search
Back to results

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

Primary Purpose

Hematological Malignancies

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fludarabine, Busulfan, Thymoglobuline
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies focused on measuring Allogeneic stem cell transplantation, Reduced-intensity conditioning, Reduced-toxicity conditioning, Hematological malignancies, IV Busulfan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut Paoli Calmettes
  • CHU de Nantes
  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Busilvex, Fludara, Thymoglobuline

Arm Description

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
February 10, 2009
Last Updated
May 15, 2012
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00841724
Brief Title
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Acronym
ITT 08-01
Official Title
Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
Keywords
Allogeneic stem cell transplantation, Reduced-intensity conditioning, Reduced-toxicity conditioning, Hematological malignancies, IV Busulfan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Busilvex, Fludara, Thymoglobuline
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fludarabine, Busulfan, Thymoglobuline
Primary Outcome Measure Information:
Title
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation
Time Frame
12 months after transplantation
Secondary Outcome Measure Information:
Title
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
Time Frame
12 months after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Mohty, MD, PhD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs