NCT03912064

A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for this specific disease but it has been approved for other uses. This drug has been used in other research studies and is now FDA-approved for the treatment of melanoma. Many people have also received ipilimumab on research studies for possible treatment of prostate cancer, lymphoma, kidney cancer, ovarian cancer and HIV infection. Information from those other research studies suggests that ipilimumab may help to treat the participant's cancer. Ipilimumab is an antibody that acts against CTLA-4. An antibody is a common type of protein produced by the body that the immune system (a system that defends the body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in the body) such as bacteria and viruses.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Myeloproliferative Neoplasms
• Chronic Myelomonocytic Leukemia
• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab is an antibody that acts against CTLA-4
BIOLOGICAL	CD25hi Treg depleted DLI	Donor lymphocyte product

Timeline

• Start date: 2019-07-10
• Primary completion: 2024-05-24
• Completion: 2026-12-31
• First posted: 2019-04-11
• Last updated: 2026-01-05
• Results posted: 2026-01-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study