Automated radiation could make stem cell transplants safer for blood cancer patients
NCT ID NCT07634536
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new automated radiation method that precisely targets bone marrow and lymph nodes before a stem cell transplant. The goal is to kill cancer cells while reducing damage to healthy tissues. Participants have high-risk myeloid cancers like acute myeloid leukemia or myelodysplastic syndromes. The study will check if this approach is safe and helps patients recover without severe side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Automated total marrow and lymphoid irradiation (TMLI) with fludarabine and cyclophosphamide
- What this could lead to
- If successful, this automated radiation approach could make stem cell transplants safer and more effective for people with high-risk blood cancers.
- What could go wrong
- This is a small, early-phase trial, so results may not apply to all patients. Radiation and chemotherapy still carry risks of serious side effects, including infection and organ damage.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
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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18 to 70 years
- 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 for 20 Gy Arm (Cohort A) 1. Age, Performance Status, and Graft Criteria require all of the following bullet points: * Age 18 to 60 years (inclusive) * HCT Co-Morbidity score (HCT-CI) \< 5 (http://www.qxmd.com/calculate-online/hematology/hct-ci)(31) * Adequate performance status is defined as Karnofsky score ≥ 70% * Patients must be receiving an allogeneic peripheral blood stem cell graft * Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors may be an 8/8 matched sibling donor, 8/8 matched unrelated donor, haploidentical related donor, or 7/8 mismatched unrelated donor. 2. Eligible Diseases (Any one of the following) Acute Myeloid Leukemia (AML) Must have at least one of the following characteristics: * Blasts \>5% in the peripheral blood and/or bone marrow after \>2 prior lines of AML directed therapy, present during the trial screening window * Adverse plus risk by AlloHCT Refined ELN Criteria: defined as having complex cytogenetics, TP53 mutation, or MECOM rearrangement confirmed at any time point.(32) Myelodysplastic syndrome Must have at least one of the following characteristics at the time of conditioning: * Blasts \>10% in the peripheral blood and/or bone marrow after \>1 prior line of therapy. * TP53 mutation confirmed at any time point Myeloproliferative neoplasms (MPN) or MDS/MPN overlap. Must have at least one of the following characteristics: * Blasts \>10% in the peripheral blood and/or bone marrow during the trial screening window * TP53 mutation confirmed at any time point 3. Adequate organ function is defined as all of the following: Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45% confirmed by MUGA or echocardiography Pulmonary: DLCO, FEV1, FVC \> 50% predicted, and absence of O2 requirements. Liver: Transaminases \< 3 x upper limit of normal (ULN) and total bilirubin ≤ 2 mg/dL except for patients with Gilbert's syndrome or hemolysis (as indicated by provider documentation). Renal: Creatinine \< 2.0 mg/dL (adults) and creatinine clearance \> 40 mL/min. 4. Must be FIRST allogeneic HCT 5. Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment. 6. Voluntary written consent Inclusion Criteria for 12 Gy Arm (Cohort B) 1. Age, Performance Status, and Graft Criteria require all of the following bullet points: Age 18 to 70 years (inclusive) Adequate performance status is defined as Karnofsky score ≥ 70% Patients must be receiving an allogeneic peripheral blood stem cell graft Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors may be an 8/8 matched sibling donor, 8/8 matched unrelated donor, haploidentical related donor, or 7/8 mismatched unrelated donor. 2. Eligible Diseases (Any of the following) Acute Myeloid Leukemia (AML) Myelodysplastic syndrome Myeloproliferative neoplasm MDS/MPN overlap 3. Must have relapse after prior allo HCT 4. Adequate organ function is defined as all of the following: Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40% confirmed by MUGA or echocardiography Pulmonary: DLCO, FEV1, FVC \> 40% predicted, and absence of O2 requirements. Liver: Transaminases \< 3 x upper limit of normal (ULN) and total bilirubin ≤ 2 mg/dL except for patients with Gilbert's syndrome or hemolysis (as indicated by provider documentation). Renal: Creatinine \< 2.0 mg/dL (adults) and creatinine clearance \> 40 mL/min. Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment. 5. Voluntary written consent Exclusion Criteria: 1. Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy. 2. Untreated active infection. Controlled or asymptomatic infections requiring continued antimicrobial therapy are permissible. 3. Active HIV infection, defined as HIV infection with detectable viral load 4. Active central nervous system malignancy 5. GVHD requiring systemic therapy including \> 0.25 mg/kg prednisone (or equivalent) or other systemic therapy for GVHD (e.g., tacrolimus, sirolimus, ruxolitinib, belumosodil, ibrutinib, axatilimab). 6. Any other medical or psychological condition that is deemed serious and unsafe for clinical trial participation. 7. Exposure to prior radiation that is deemed unsafe for clinical trial participation.
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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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Stanford University
Palo Alto, California, 94304, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a p53-Targeting drug boost chemotherapy in Hard-to-Treat blood cancers?
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication