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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: Recruiting Phase 1 study of Myelodysplastic Syndromes and Graft Vs Host Disease, sponsored by Dana-Farber Cancer Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Safety will be assessed by dose-limiting toxicities (DLT) summarized by patient, type and grade as defined by the CTCAE v5.0.
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 |
What NCT04678401 shows while recruiting
NCT04678401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04678401's enrollment target sits among peer trials
30 120th of 173 higher than 51 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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