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

Institut Paoli-Calmettes

Status and phase: Completed; Phase 2

Conditions: Solid Tumor; Allogeneic Cell Transplantaion; Hematological Malignancy; Allograft

Treatments: Drug: reduced intensity conditionings

Study type: Interventional

Funder types: Other

Identifiers

NCT00894049

ITAC02-01

Details and patient eligibility

About

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).

Enrollment: 148 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Flu-Bu-ATG

Experimental group

Description:

Fludarabine (30mg/m²/5 days) Oral Busulfan (8 mg/kg over 2 days) Thymoglobuline (2.5 mg/m²/1day).

Treatment:

Drug: reduced intensity conditionings

Fluda-TBI

Experimental group

Description:

Fludarabine (25mg/m²/ 3 days) 2 Gy TBI

Treatment:

Drug: reduced intensity conditionings