Standard-of-Care Reduced-Intensity Conditioning (RIC) With 200 Versus 400 cGy of Total Body Irradiation (TBI) in Patients With Acute Leukemia Undergoing First Allogeneic Blood or Marrow Transplantation (BMT)
NCT06803745 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-04-06
Summary
This is a randomized phase II trial of standard-of-care reduced-intensity conditioning (RIC) with 200 versus 400 cGy of total body irradiation (TBI) in patients with acute leukemia undergoing first allogeneic blood or marrow Transplantation (BMT). The primary objective is to compare the rates of graft-versus-host disease-free and relapse-free survival (GRFS) between patients in the two cohorts.
Conditions
- Acute Leukemia
- Acute Lymphoblastic Lymphoma
Interventions
- RADIATION
-
200 cGy or 400 cGy total body irradiation (TBI)
Either 200 or 400cGy will be given as part of reduced-intensity conditioning prior to consolidative allogeneic bone marrow transplant (alloBMT)
Sponsors & Collaborators
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Jonathan Webster · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-27
- Primary Completion
- 2030-03-31
- Completion
- 2030-09-30
Countries
- United States
Study Locations
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