A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT
NCT03912064 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-01-05
Summary
In this research study, our main goal for the ipilimumab portion of the study is to determine the highest dose of ipilimumab that can be given safely in several courses and to determine what side effects are seen in patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasms (MPN), Chronic Myelomonocytic Leukemia (CMML), or Myelofibrosis (MF).
Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Myeloproliferative Neoplasms
- Chronic Myelomonocytic Leukemia
- Myelofibrosis
Interventions
- DRUG
-
Ipilimumab is an antibody that acts against CTLA-4
- BIOLOGICAL
-
CD25hi Treg depleted DLI
Donor lymphocyte product
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
John Koreth, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-10
- Primary Completion
- 2024-05-24
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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