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NCT03912064 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT03912064: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Dana-Farber Cancer Institute.
NCT03912064 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 25 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03912064, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol.
Conditions Studied
Interventions
- DRUG Ipilimumab
- BIOLOGICAL CD25hi Treg depleted DLI
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03912064 still lists
NCT03912064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (78% lower).
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.
NCT03912064 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03912064 about?
NCT03912064 is a clinical study titled "A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT". 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), Myelopr...
What is the current status of trial NCT03912064?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-07-10. Estimated completion is 2026-12-31.
What conditions does trial NCT03912064 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Myelofibrosis, Myeloproliferative Neoplasms.
What interventions are being tested in trial NCT03912064?
The interventions under investigation include: Ipilimumab (DRUG), CD25hi Treg depleted DLI (BIOLOGICAL).
Who is sponsoring clinical trial NCT03912064?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03912064 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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