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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002548-12-BE

Enrollment

Registered

2007-12-03

Start date

2007-12-17

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Belgium, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026