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A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation (ITAC02-01)

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ClinicalTrials.gov Identifier: NCT00894049
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : January 1, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).

Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).

Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).

A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.

Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).

Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.

Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).


Condition or disease Intervention/treatment Phase
Allograft Allogeneic Cell Transplantaion Hematological Malignancy Solid Tumor Drug: reduced intensity conditionings Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation
Study Start Date : November 2002
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Flu-Bu-ATG
Fludarabine (30mg/m²/5 days) Oral Busulfan (8 mg/kg over 2 days) Thymoglobuline (2.5 mg/m²/1day).
Drug: reduced intensity conditionings
comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)
Experimental: Fluda-TBI
Fludarabine (25mg/m²/ 3 days) 2 Gy TBI
Drug: reduced intensity conditionings
comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)


Outcome Measures

Primary Outcome Measures :
  1. one year overall survival (OS) [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hematological malignancy or solid tumor,
  • eligible for non myeloablative allogenic transplantation,
  • aged between 18 and 65,
  • with a suitable HLA identical sibling

Exclusion Criteria:

  • contra-indication to allogenic transplantation
  • pregnant women or breast feeding
  • active infection
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894049


Locations
France
CHU
Bordeaux Pessac, France
CHU
Clermont Ferrand, France
CHU
Lyon, France
Institut Paoli-Calmettes
Marseille, France
CHU
Montpellier, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Didier BLAISE, PUPH Institut Paoli-Calmettes
More Information

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00894049     History of Changes
Other Study ID Numbers: ITAC02-01
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: January 1, 2014
Last Verified: December 2013