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Automated radiation could make stem cell transplants safer for blood cancer patients

NCT ID NCT07634536

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Stanford University

    Palo Alto, California, 94304, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.