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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03912064
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab is an antibody that acts against CTLA-4
  • CD25hi Treg depleted DLI — BIOLOGICAL
    Donor lymphocyte product

Study Details

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).

Key Dates

Start date
Jul 10, 2019
Status verified
Dec 2025
Primary completion
May 24, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD25/Treg-depleted DLI + Ipilimumab
    * Ipilimumab is administered intravenously every 12 weeks * Patients will receive a defined dose of CD25hi Treg depleted DLI intravenously

Primary Outcome Measure

Maximum Tolerated Dose (MTD) for DLI [ Time Frame: Day 43 (6 weeks) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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