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)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
Description
This research is being done to learn more about reduced-intensity conditioning stem cell transplant for patients with acute leukemias or acute lymphoblastic lymphoma, using stem cell donation from the peripheral blood or bone marrow from a relative or an unrelated donor. The purpose of this study is to determine if a TBI dose of 400 cGy yields better transplant-related outcomes than a TBI dose of 200 cGy when leukemia patients in remission undergo a reduced-intensity conditioning transplant using high-dose post-transplantation cyclophosphamide as GVHD prophylaxis. The study will use graft-ver…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 0 years 2. Patients with a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia or lymphoma (ALL), or acute leukemia of mixed or ambiguous lineage per the 2022 World Health Organization classifications,75,76 with \< 5% blasts on bone marrow morphologic analysis performed within 30 days of planned conditioning initiation 1. AML is generally defined as ≥ 20% myeloid blasts identified in the peripheral blood and/or bone marrow. Myeloid sarcoma is also recognized as an AML-defining entity. Situations in which AML can be diagnosed without a speci…
Interventions
- Radiation200 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)
Location
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland