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NCT05088356 · ClinicalTrials.gov registry record · Phase 1
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
A Phase 1 study of Myelodysplastic Syndromes and Acute Leukemia, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05088356: Recruiting Phase 1 study of Myelodysplastic Syndromes and Acute Leukemia, sponsored by Stanford University.
NCT05088356 is a Phase 1 study of Myelodysplastic Syndromes and Acute Leukemia that is actively recruiting participants, run by Stanford University. The registered enrollment target is 60 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05088356, a Phase 1 study of Myelodysplastic Syndromes and Acute Leukemia, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.
Primary Outcome
Clinical effect will be assessed as graft vs host disease (GVHD)-free relapse free survival (GRFS), GVHD-free is defined as no GVHD symptoms, and relapse free survival is defined as survival at 12 months without relapse. The outcome will be measured in Arm A only.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Tacrolimus
- DRUG Purified regulatory T-cells (Treg) plus CD34+ HSPC
- DEVICE CliniMACS CD34 Reagent System
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-09-07 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
What NCT05088356 shows while recruiting
NCT05088356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (79% lower).
The record links to 6 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT05088356 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05088356 about?
NCT05088356 is a clinical study titled "Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft". Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matche...
What is the current status of trial NCT05088356?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-09-07. Estimated completion is 2027-11.
What conditions does trial NCT05088356 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Acute Leukemia, Chronic Myelogenous Leukemia, Myeloproliferative Disorders, Allogeneic Hematopoietic Cell Transplantation (HCT).
What interventions are being tested in trial NCT05088356?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Tacrolimus (DRUG), Purified regulatory T-cells (Treg) plus CD34+ HSPC (DRUG), CliniMACS CD34 Reagent System (DEVICE).
Who is sponsoring clinical trial NCT05088356?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05088356 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05088356's enrollment target sits among peer trials
60 75th of 173 higher than 96 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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