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NCT06815003 · ClinicalTrials.gov registry record · Phase 2
Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT06815003: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
NCT06815003 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 35 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06815003, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.
Primary Outcome
Will be assessed as an unacceptable toxicity (UT). Will include type, severity, duration, and attribution/association with the study regimen and dose limiting toxicity (DLT) occurrence. Tables will be constructed to summarize the observed incidence, severity, and type of toxicity, including, but not limiting infections, other adverse events of special interest, and severe adverse events. Point estimates and corresponding exact 90% confidence intervals (CIs) will be provided for each measure of t
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2025-04-18 |
| Est. Completion | 2028-10-15 |
| Phase | Phase 2 |
What NCT06815003 shows while recruiting
NCT06815003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (70% lower).
The record links to 6 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06815003 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06815003 about?
NCT06815003 is a clinical study titled "Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning". This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allog...
What is the current status of trial NCT06815003?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2025-04-18. Estimated completion is 2028-10-15.
What conditions does trial NCT06815003 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Chronic Myelomonocytic Leukemia, Graft-Versus-Host Disease.
What interventions are being tested in trial NCT06815003?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT06815003?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06815003 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 NCT06815003's enrollment target sits among peer trials
35 192nd of 306 higher than 113 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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