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

Solid Tumor Clinical Trial

— ITAC02-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894049
• Other study ID #: ITAC02-01
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2009
• Last updated: December 31, 2013
• Start date: November 2002
• Est. completion date: February 2013

Study information

• Verified date: December 2013
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allogeneic Cell Transplantaion
• Allograft
• Hematological Malignancy
• Solid Tumor

Intervention

Drug:
• reduced intensity conditionings
comparison of non myeloablative (Flu-TBI) and reduced intensity (FLU-BU-ATG)

Locations

Country	Name	City	State
France	CHU	Bordeaux Pessac
France	CHU	Clermont Ferrand
France	CHU	Lyon
France	Institut Paoli-Calmettes	Marseille
France	CHU	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one year overall survival (OS)		one year	Yes

External Links

•   official site of the sponsor