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NCT04678401 · ClinicalTrials.gov registry record · Phase 1
IS-free Treg HaploHCT
A Phase 1 study of Myelodysplastic Syndromes and Graft Vs Host Disease, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04678401 is a Phase 1 study of Myelodysplastic Syndromes and Graft Vs Host Disease that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 30 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04678401, a Phase 1 study of Myelodysplastic Syndromes and Graft Vs Host Disease, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory and Ultra-high risk acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT). The names of the study interventions involved in this study are: * Radiation-Total Myeloid and Lymphoid Irradiation (TMLI) * Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna) * Infusion of haplo Treg-enriched donor cells (experimental therapy) * Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells) * Infusion of haplo donor CD34+ Peripheral Blood Stem Cells
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DRUG Thiotepa
- RADIATION Radiation
Study Locations (1)
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04678401
The ClinicalTrials.gov registry entry for NCT04678401 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (89% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04678401 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04678401 about?
NCT04678401 is a clinical study titled "IS-free Treg HaploHCT". This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory and Ultra-high risk acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoi...
What is the current status of trial NCT04678401?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-01-12. Estimated completion is 2029-08-31.
What conditions does trial NCT04678401 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Graft Vs Host Disease, Stem Cell Transplant Complications, Myeloid Leukemia, Acute, Myeloid Leukemia in Relapse (Disorder).
What interventions are being tested in trial NCT04678401?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), Thiotepa (DRUG), Radiation (RADIATION).
Who is sponsoring clinical trial NCT04678401?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04678401 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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