Comparing Radiation Doses for Acute Leukemia Transplant

This study is for patients with acute leukemia or acute lymphoblastic lymphoma who are having their first allogeneic blood or marrow transplant (BMT). Researchers want to compare two different doses of total body irradiation (TBI), which is a type of radiation therapy: 200 cGy or 400 cGy. This radiation is given before the transplant as part of a reduced-intensity conditioning regimen. The goal is to see which dose leads to better outcomes, specifically looking at how many patients are free from graft-versus-host disease (a complication where donor cells attack the patient's body) and relapse of their leukemia after two years. You can join if you are at least 0 years old and have less than 5% blasts in your bone marrow.

Study design
This is a randomized study comparing two different radiation doses in 160 participants. It is designed to see which dose leads to better outcomes after a stem cell transplant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least two years to measure graft-versus-host disease-free, relapse-free survival.

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NCT06803745

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)

Recruiting
NAAll AgesInterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~160 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:200 cGy or 400 cGy total body irradiation (TBI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
graft-versus-host disease-free, relapse-free survival (GRFS)
Measured over 2 years
Acute Leukemia
Acute Lymphoblastic Lymphoma
1 sites across 1 states
Maryland1
  • Jonathan Webster · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Eligibility criteria

Inclusion

i. MPN includes myelofibrosis, essential thrombocythemia, polycythemia vera, chronic neutrophilic leukemia, chronic eosinophilic leukemia, juvenile myelomonocytic leukemia, chronic myeloid leukemia (CML), or myeloproliferative neoplasm, not otherwise specified
ii. Myelodysplastic syndrome or neoplasm (MDS)
iii. MDS/MPN-overlap includes chronic myelomonocytic leukemia (CMML), myelodysplastic/myeloproliferative neoplasm with neutrophilia, myelodysplastic/myeloproliferative neoplasm with SF3B1 mutation and thrombocytosis, or myelodysplastic/myeloproliferative neoplasm, not otherwise specified
iv. Of note, patients without a documented history of one of these conditions prior to diagnosis of acute myeloid leukemia with myelodysplastic features would not be restricted to this specific criterion for study inclusion. 3. No active extramedullary leukemia or known active Central Nervous System (CNS) involvement by malignancy. Such disease treated into remission is permitted. 4. Patients must have a related or unrelated bone marrow or peripheral blood donor
  • graft-versus-host disease-free, relapse-free survival (GRFS)2 years

    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