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.
Age ≥ 0 years
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
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 specific blast threshold met nor myeloid sarcoma present are when fusions involving RUNX1::RUNX1T1, CBFB::MYH11, DEK:NUP214, or RBM15::MRTFA are present; rearrangements involving KMT2A, MECOM, or NUP98 exist; or there is a mutation in NPM1.
B- or T-ALL is defined as the presence of lymphoid blasts identified in the peripheral blood and/or bone marrow with no specific blast threshold needed (acute lymphoblastic leukemia) or the presence of a lymphatic-based collection of lymphoblasts (acute lymphoblastic lymphoma).
None
Parallel
200 cGy or 400 cGy total body irradiation (TBI)
RadiationEither 200 or 400cGy will be given as part of reduced-intensity conditioning prior to consolidative allogeneic bone marrow transplant (alloBMT)
graft-versus-host disease-free, relapse-free survival (GRFS)
Number of patients without grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause from time of transplant until end of study
Overall survival (OS)
Number of patients surviving from day of transplant until end of study
Relapse-free survival (RFS)
Number of patients who are disease relapse free from time of transplant until end of study
Relapse Incidence
Cumulative incidence of relapse in each treatment arm from time of transplant until end of study
Non-relapsed mortality (NRM)
Number of people who died without disease relapse in each treatment arm from time of transplant until end of study
Incidence of Toxicities Grade ≥3 NCI CTCAE
Number of grade ≥ 3 toxicities occurring Grade ≥ 3 toxicities occurring from time of transplant until day +56
Incidence of Noninfective (Hemorrhagic Cystitis), Grade ≥2 NCI CTCAE
Number of grade ≥ 2 noninfective cystitis events occurring from time of transplant until day +56
Maximal Grade of Fatigue
maximal grade of fatigue according to the NCI CTCAE grading system from time of transplant until Day +56
Incidence of new malignancies
All malignancies newly diagnosed after beginning the conditioning regimen until end of study
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