Leukemia transplant study tests lower radiation for better outcomes
NCT ID NCT06803745
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tests whether a lower dose of total body irradiation (200 cGy) before a bone marrow transplant works as well as a standard higher dose (400 cGy) for people with acute leukemia. The goal is to see which dose leads to fewer severe side effects like graft-versus-host disease and better survival without relapse. About 160 participants will be randomly assigned to one of the two radiation doses as part of their transplant preparation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- total body irradiation (TBI) at 200 or 400 cGy
- What this could lead to
- If it works, this could identify the best radiation dose to reduce severe complications and improve long-term survival after transplant for leukemia patients.
- What could go wrong
- This is a phase 2 trial with only 160 participants, so results may not apply to everyone. Radiation can cause side effects, and the lower dose might not control the disease as well.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. 2. 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). 3. Acute leukemia of mixed or ambiguous lineage is defined as mixed or ambiguous lineage blasts identified in the peripheral blood and/or bone marrow or the presence of a lymphatic-based collection (lymphoma) of mixed or ambiguous lineage blasts. A specific blast threshold does not need to be met. 4. Patients with a documented diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and/or MDS/MPN-overlap prior to diagnosis of acute leukemia may be included for randomization in this clinical trial so long as the patient has received at least 4 cycles of DNA methyltransferase inhibitor (e.g., azacitidine, decitabine, decitabine/cedazuradine (Inqovi), and/or any other agent that works via this mechanism) or at least one cycle of induction chemotherapy. A list of antecedent diagnoses per the World Health Organization 2022 classification of hematolymphoid tumors that pertain to this inclusion criterion are listed below 75 * 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 1. Human leukocyte antigen (HLA)-matched (10/10) sibling donor (MSD) 2. HLA-matched (10/10) unrelated donor (MUD) 3. HLA-haploidentical (5/10) related donor (Haplo) 4. HLA-mismatched (5-9/10) unrelated donor (mMUD) 5. Planned allogeneic BMT using post-transplantation cyclophosphamide (PTCy) as a component of GVHD prophylaxis 6. Adequate end-organ function as measured by: 1. Left ventricular ejection fraction greater than or equal to 35% or shortening fraction \> 25% 2. Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x Upper Limit of Normal (ULN) 3. Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) \> 40% of predicted 7. Patients may enroll in other transplant-related trials (e.g., those testing post-transplant maintenance strategies or peri-transplant strategies for the management of donor specific antibodies) as long as other eligibility criteria are met and the requirements do not conflict with the treatment plan as outlined herein. Patients may also receive standard of care post-transplant maintenance therapies. Exclusion Criteria: 1\) Acute leukemia with promyelocytic leukemia (PML)/retinoic acid receptor α (RARA) fusion 2)2) Documented, clinical diagnosis of myeloproliferative neoplasm (MPN), myelodysplastic syndrome or neoplasm (MDS), and/or MDS/MPN-overlap based on the World Health Organization 2022 classification prior to diagnosis of acute leukemia.75 Patients with a diagnosis of AML with myelodysplastic features based on cytogenetic or genetic features and without an antecedent clinical history of MPN, MDS, and/or MDS/MPN-overlap are not excluded. 3\) Prior allogeneic BMT 4) Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2 or Karnofsky/Lansky score \< 60 5) Patients with an additional active malignancy with a life expectancy \< 2 years due to that disease 6) Symptomatic coronary artery disease 7) Uncontrolled infection 8) Patients who are pregnant or breastfeeding 9) Body mass index (BMI) \> 45 kg/m2
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
RECRUITINGBaltimore, Maryland, 21287, United States
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