Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings - Minitransplant-Random TBI vs TLI

Phase 1

• Conditions: Patients with hematological malignancies not candidate for conventional allogeneic transplantation because of age or comorbidities; MedDRA version: 9.1Level: LLTClassification code 10001756Term: Allogenic bone marrow transplantation therapy

• Registration Number: EUCTR2007-002548-12-BE
• Lead Sponsor: CHU-ULG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-03
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Hematological malignancies confirmed histologically and not rapidly progressing.
2. Ineligible for conventional allogeneic transplantation because of age or comorbidities.
3. 10/10 HLA-allele-matched related or unrelated donors.
4. Male or female; fertile patients must use a reliable contraception method;
5. Age < 75 yrs;
6. Informed consent given by patient or his/her guardian if of minor age.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. HIV positive;
2. Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT.
3. Life expectancy severely limited by disease other than malignancy;
4. Administration of cytotoxic agent(s) for cytoreduction” within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
5. CNS involvement with disease refractory to intrathecal chemotherapy.
6. Terminal organ failure, except for renal failure (dialysis acceptable)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The present project aims at comparing two nonmyeloablative regimens currently used in 2 major transplant centers in the US for patients with HLA-matched related or unrelated donor: the one from the Seattle group consisting of 2 Gy total body irradiation (TBI) with fludarabine (90 mg/m²) versus the one from the Stanford group combining 8 Gy total lymphoid irradiation (TLI) with anti-thymocyte globulin (ATG). Tte primary objective is to compare the incidence of grade II-IV acute GVHD between the 2 groups.;Secondary Objective: To compare immunologic reconstitution and infectious complications with these two conditioning regimens.;Primary end point(s): To compare the incidence of grade II-IV acute graft-versus-host disease (GVHD) between the 2 groups.