Study on Vedolizumab, Cyclophosphamide, and Tacrolimus to Prevent Graft Versus Host Disease in Patients Undergoing Stem Cell Transplant

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06815003

Provider View

This clinical trial is testing a combination of drugs, including vedolizumab, cyclophosphamide, and tacrolimus, to prevent graft versus host disease (GVHD) in patients receiving stem cell transplants from donors. The study aims to see if this combination can effectively prevent GVHD after a transplant.

Patient Parameters

Program Overview

This study is exploring whether a combination of drugs—vedolizumab, cyclophosphamide, and tacrolimus—can help prevent graft versus host disease (GVHD) in patients undergoing stem cell transplants from donors. GVHD is a condition where the donor's cells attack the patient's body. The study involves using reduced doses of chemotherapy before the transplant to make room for new stem cells. Vedolizumab is a protein that may reduce inflammation, cyclophosphamide is a drug that can kill cancer cells and lower immune response, and tacrolimus helps suppress the immune system. The goal is to see if this combination can effectively prevent GVHD after the transplant.

Description

The main goals of this study are to ensure the safety of adding vedolizumab to the standard treatment for preventing graft versus host disease (GVHD) after a stem cell transplant and to see if it helps patients avoid GVHD. The study will also look at how well patients do overall, including survival rates and cancer progression, and monitor for any side effects or complications.

Participants will receive a reduced intensity chemotherapy regimen before the transplant to prepare their bodies. After the transplant, they will receive vedolizumab, cyclophosphamide, and tacrolimus to help prevent GVHD. The study will involve regular check-ups, including blood tests and scans, to monitor the patients' health and the effectiveness of the treatment.

The study will also explore how the immune system recovers after the transplant, the quality of life of participants, and changes in the gut microbiome. Participants will be followed up for a year after the transplant to gather comprehensive data on the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Agree to allow the use of previous tumor biopsy samples if available.
  • Aged between 18 and 80 years old.
  • Have a good performance status and meet specific health criteria.
  • Diagnosed with certain types of blood cancers and eligible for a stem cell transplant from a matched donor.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Not have any active infections or other serious health conditions.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.

Exclusion Criteria

  • Have had a previous stem cell transplant.
  • Have received certain treatments within 14 days before starting the study.
  • Are taking other investigational drugs for GVHD prevention.
  • Have a history of severe allergic reactions to similar drugs.
  • Have uncontrolled illnesses or active infections.
  • Have another active cancer that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Are unable to commit to follow-up visits for at least 100 days after the transplant.
  • Have any condition that the study doctor believes would make participation unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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