RecruitingPhase 2NCT06815003

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

Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation


Sponsor

City of Hope Medical Center

Enrollment

35 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of drugs to prevent graft-versus-host disease (GVHD) — a serious complication where donated immune cells attack the recipient's body after a bone marrow or stem cell transplant. The combination includes vedolizumab (a gut-protective drug), cyclophosphamide (a chemotherapy used to suppress the immune system after transplant), and a short course of tacrolimus (an immune-suppressing drug). **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with a blood cancer such as leukemia, lymphoma, or myelodysplastic syndrome - You are scheduled to receive a reduced-intensity stem cell or bone marrow transplant from a matched donor - You are in reasonably good physical condition (Karnofsky score of 70% or higher) **You may NOT be eligible if...** - You have active uncontrolled infection - You have significant organ damage (heart, liver, kidney) - You are pregnant or breastfeeding - You have had a prior stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HCT

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT

DRUGCyclophosphamide

Given IV

PROCEDUREEchocardiography

Undergo ECHO

DRUGFludarabine

Given IV

DRUGMelphalan

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

OTHERQuestionnaire Administration

Ancillary studies

DRUGTacrolimus

Given IV or PO

BIOLOGICALVedolizumab

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06815003


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