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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00894049
First received: May 5, 2009
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Allograft
Allogeneic Cell Transplantaion
Hematological Malignancy
Solid Tumor
Drug: reduced intensity conditionings
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • one year overall survival (OS) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 148
Study Start Date: November 2002
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: reduced intensity conditionings
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)
Other Name: reduced intensity conditionings

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00894049     History of Changes
Other Study ID Numbers: ITAC02-01
Study First Received: May 5, 2009
Last Updated: December 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014