New hope for older blood cancer patients: lower-dose combo may reduce transplant complications
NCT ID NCT05622318
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a lower-dose combination of two drugs (PTCy and ruxolitinib) can prevent graft-versus-host disease (GVHD) in older adults receiving a stem cell transplant for blood cancer. About 56 participants will receive the treatment and be monitored for survival without severe GVHD. The goal is to make transplants safer by reducing harmful immune reactions while still controlling the cancer.
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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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56 people
The number who actually took part.
- Started
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Aug 2023
- Expected to finish
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Sep 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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60 years and older
- 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. History of hematologic malignancy. 2. Must be in remission: * Acute Leukemia, chronic leukemia, or myelodysplasia/myeloproliferative neoplasm (excluding primary myelofibrosis): No circulating blasts and \<5% blasts in the bone marrow. * Hodgkin and non-Hodgkin lymphomas: Chemo-sensitive disease at time of transplant 3. Patients must have a related or unrelated peripheral blood stem cell donor that is an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donors must be willing to donate peripheral blood stem cells and meet NMDP criteria for donation. 4. Planned reduced intensity conditioning therapy with fludarabine/melphalan, with total dose of melphalan of 100-140 mg/m\^2 IV or fludarabine/busulfan with total dose of busulfan of 6.4 mg/kg IV. 5. Karnofsky Performance Scale of 60 or greater. 6. Male participants must agree to abstinence or to use of barrier contraception during the entire study period. 7. Female participants of childbearing potential will require a negative pregnancy test and should agree to practice two effective methods of contraception during the entire study period. 8. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Prior allogeneic HCT or Chimeric antigen receptor (CAR) -T cell therapy. 2. Patients with liver dysfunction evidenced by bilirubin ≥2x upper limit normal (ULN), except for a history of Gilbert syndrome. 3. Patients with renal impairment defined by creatinine\<2mg/dL. 4. Patients with cardiac dysfunction defined by a left ventricular ejection fraction ≤45%. 5. Patients with pulmonary dysfunction defined by a forced expiratory volume in the first second (FEV1) or diffusing capacity for carbon monoxide (DLCO) (corrected for hemoglobin) ≤50% of predicted. 6. Patients with a chronic or active infection requiring systemic treatment during and after transplant. 7. Presence of other active malignant disease diagnosed within 12 months, except for adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment. 8. Pregnant or lactating subjects.
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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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Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Can adding rituximab improve remission in chronic GVHD?
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?