Vedolizumab + Cyclophosphamide + Tacrolimus for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

Overseen byMonzr M Al Malki

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for patients with certain blood cancers or disorders who are undergoing a stem cell transplant from a donor after receiving lower doses of chemotherapy. It aims to prevent the immune response where transplanted cells attack the patient's body (GVHD).

Inclusion Criteria

* Documented informed consent of the participant and/or legally authorized representative

* Assent, when appropriate, will be obtained per institutional guidelines

* Agreement to allow the use of archival tissue from diagnostic tumor biopsies

+7 more

Participant Groups

The study tests if vedolizumab, combined with cyclophosphamide and short-term tacrolimus after transplant, can prevent GVHD in patients receiving reduced intensity conditioning before allogeneic hematopoietic cell transplantation.

1Treatment groups

Experimental Treatment

Group I: Prevention (vedolizumab, cyclophosphamide, tacrolimus)Experimental Treatment12 Interventions

Patients receive reduced intensity conditioning with fludarabine IV on days -7 to -3 and melphalan IV on day -2. Patients then undergo allogeneic HCT on day 0. Patients also receive vedolizumab IV over 30 minutes on days -1, +13, +41, +69, +97, +125, and +153, cyclophosphamide IV on days +3 and +4, and tacrolimus IV or PO on day +5 to day +95 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT and ECHO or MUGA during screening, blood sample collection on study, and bone marrow biopsy throughout the study.