Radiation boost may help stem cell transplants beat tough leukemia
NCT ID NCT03121014
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether adding targeted total marrow irradiation to standard chemotherapy before a stem cell transplant can help prevent relapse in people with high-risk acute myeloid leukemia or myelodysplastic syndromes. About 38 adults aged 18–65 will receive the combined treatment. The main goal is to see if more patients survive one year without their cancer returning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fludarabine, Busulfan, ATG, Tacrolimus, and total marrow irradiation
- What this could lead to
- If successful, this could improve the chance of staying cancer-free after a stem cell transplant for people with hard-to-treat leukemia or myelodysplastic syndromes.
- What could go wrong
- This is a small, early-phase study (38 participants) with no control group. The intense treatment carries serious risks like infection, organ damage, and graft-versus-host disease. Results may not apply to all patients.
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
-
About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2017
- Expected to finish
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Apr 2026
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 65 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: 1. Age 18-65 years 2. Patients with AML or MDS who meet the following criteria: a. Relapsed or refractory AML (including AML in CR2) b. Poor-risk AML in first remission, with remission defined as \<5% bone marrow blasts morphologically: * AML arising from MDS or a myeloproliferative disorder, or secondary AML * Poor risk molecular features including presence of FLT3 internal tandem duplication mutation. * Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\> 3 abnormalities), inv(3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7 c. Primary refractory disease d. MDS with at least one of the following poor-risk features: * Poor-risk cytogenetics including 3q abnormalities, 7/7q minus or complex cytogenetics (\>3 abnormalities) * Current or previous INT-2 or high IPSS score * Treatment-related MDS * MDS diagnosed before age 21 years * Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy * Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions e. CML with a history of accelerated or blast phase 3. Patients must have a related or unrelated peripheral blood stem cell donor as follows: 1. Sibling donor must be a 6/6 match for HLA-A, -B at intermediate (or higher) resolution and -DRB1 at high resolution using DNA based typing 2. Unrelated donors must be at least 7/8 match at HLA-A, -B, -C and DRB1 at high resolution using DNA-based typing Exclusion criteria: 1. Presence of significant co morbidity as shown by: 1. Left ventricular ejection fraction \< 50% 2. Creatinine clearance \<30ml/min 3. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN 4. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia f. Karnofsky score \<70 (appendix C) g. Hematopoietic cell transplantation comorbidity index \>3 h. Active viral hepatitis or HIV infection j. Cirrhosis 2. Pregnancy 3. Patients unable to sign informed consent 4. Patient who have previously received radiation to \>20% of bone marrow containing areas. 4\. DONOR ELIGIBILITY AND SELECTION 4.1. Donor Selection Donor evaluation and selection is by standard for normal clinical practice. No study procedures are to be performed on donors. All donors must be willing to donate peripheral blood stem cells and meet institutional or NMDP criteria for donation. The following prioritization will be used when selecting donors: 1. When possible, an HLA compatible sibling will be used as a donor. 2. For patients who do not have an HLA compatible sibling, an unrelated donor will be used 3. 8/8 matched unrelated donors are preferred over single antigen mismatched donors. If more than one potential volunteer unrelated donor is considered suitable further selection of the most suitable donor is at the discretion of the treating physician. The following serves only as a guide for prioritization: 1. Age of donor (18-24 \> 25-34 \> 35-44 \> 45+) 2. Sex and parity of donor (male \> female, nulliparous female \> parous, multiparous female) 3. Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- \> CMV+)
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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.
Contacts and locations
Locations
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University of Illinois at Chicago
Chicago, Illinois, 60612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Can a drug and donor cells stop leukemia from returning after transplant?