Interferon-γ and Donor Leukocyte Infusion for Relapsed AML/MDS
This study is testing a new treatment for acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that has returned after an allogeneic hematopoietic stem cell transplant (a type of bone marrow transplant). It combines Interferon gamma-1b, a protein that helps the immune system, with Donor Leukocyte Infusion (DLI), which transfers healthy white blood cells from your donor to you. The goal is to see if this combination can help your immune system fight off the remaining cancer cells. Researchers will also study your leukemia cells to understand how they respond to Interferon gamma-1b. To join, you must be at least 18 years old and have relapsed AML or MDS after a transplant from a well-matched donor. The main goal is to see how long people live without the cancer returning (event-free survival) after one year. The study is currently recruiting about 45 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 45 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to measure event-free survival at one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Sawa M Ito, MD, PhD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center
Who to contact
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What this trial measures
- Event-free survival (EFS)At 1 year
Cohort 1: Occurrence of treatment failure, hematologic relapse from a CR (complete remission)/CRh/Cri), or death observed from start of IFN-γ treatment. Patients alive at 1 year after start of treatment will be censored on the date of last contact.
- Incidence of steroid- and ruxolitinib- refractory GVHD within 12 weeks after the first dose of IFN-γ12 Weeks
Cohort 2: Lack of improvement after 7 days of methylprednisolone 2 mg/kg, AND, either of the following 1. Progression of graft-vs-host disease (GVHD) compared with baseline after 10 days of ruxolitinib, based either on an objective increase in stage/grade or new organ involvement Or 2. Lack of improvement in GVHD (PR or better) compared with baseline after at least 14 days of ruxolitinib.