New combo therapy aims to stop leukemia from coming back after transplant
NCT ID NCT04187105
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a precise, targeted form of radiation to the standard chemotherapy and stem cell transplant can kill more cancer cells in the bone marrow and reduce the chance of relapse. About 27 adults with acute leukemia or myelodysplastic syndrome (MDS) will receive a half-matched (haploidentical) donor transplant along with the extra radiation. The main goal is to see if more patients stay free of both the disease and serious graft-versus-host disease one year after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- targeted radiation (total marrow irradiation) plus chemotherapy (fludarabine and cyclophosphamide) followed by a half-matched stem cell transplant
- What this could lead to
- If successful, this approach could lower the chance of leukemia or MDS returning after a stem cell transplant, improving long-term survival.
- What could go wrong
- This is a small, early-phase study (27 people) and the added radiation may increase side effects like graft-versus-host disease or other toxicities. 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
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Dec 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 75 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. Patient age 18-75 years 2. Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor. * Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype. * Unrelated donors: unrelated donors who are mismatched in one or more of the following loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1,HLA-DQB1- can be included with a maximum of 4/8 or 5/10 mismatches. 3. Eligible diagnoses are listed below. Patient must have one of the following: 1. Relapsed or refractory acute leukemia (including AML or ALL in CR2 and primary refractory leukemia). 2. Poor-risk AML in first remission: * AML arising from MDS or a myeloproliferative disorder, or secondary AML * Poor risk molecular features including but not limited to 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 3. Poor risk ALL in first remission: * Poor risk cytogenetics: Philadelphia Chromosome, t(4;11), KMT2A translocation, t(8;14), complex karyotype (⩾ 5 chromosomal abnormalities) and low hypodiploidy (30-39 chromosomes)/near triploidy (60-78 chromosomes) * Philadelphia-like ALL * Presentation WBC \>30 × 109 for B-ALL or \>100 109 for T-ALL * Age\>35 * Poor MRD clearance, defined as levels \>1 × 10-3 after induction and levels \>5 × 10-4 after early consolidation by flow cytometry 4. Myelodysplastic syndromes (MDS) with at least one of the following poor-risk features: * i. Poor-risk cytogenetics (including but not limited to 7/7q minus or complex cytogenetics) * ii. IPSS score of INT-2 or greater * iii. Treatment-related or Secondary MDS * iv. MDS diagnosed before age 21 years * v. Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy * vi. Life-threatening cytopenias, including those generally requiring greater than weekly transfusions * vii. Poor risk molecular features including but not limited to the presence of BCOR, ASXL1, p53 or RUNX1 mutations 5. Mixed lineage and biphenotypic leukemia 4. Adequate end-organ function as measured by: * a. Left ventricular ejection fraction ≥ 40% * b. Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \< 5 x ULN * c. FEV1 and FVC \> 50% of predicted Exclusion Criteria: 1. Presence of significant co morbidity as shown by: * a. Left ventricular ejection fraction \< 40% * b. Bilirubin \> 2.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \> 5 x ULN * c. FEV1 and FVC \< 50% of predicted or DLCO \<50% of predicted once corrected for anemia * d. Karnofsky score \<70 * e. History of cirrhosis 2. Patients unable to sign informed consent 3. Patient who have previously received radiation to \>20% of bone marrow containing areas (assessed by radiation oncology physician)
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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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University of Illinois Cancer Center
RECRUITINGChicago, Illinois, 60612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Engineered immune cells aim to wipe out stubborn 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?