Study on PTCy, Sirolimus, and VIC-1911 to Prevent GVHD in Stem Cell Transplant Patients

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05120570

Provider View

This clinical trial is testing a new combination of medications to prevent graft-versus-host disease (GVHD) and cancer relapse in patients undergoing stem cell transplants. The study aims to find the safest and most effective dose of the new drug VIC-1911 when used with PTCy and Sirolimus.

Patient Parameters

Program Overview

The study is exploring a new treatment approach to prevent complications like GVHD and cancer relapse after a stem cell transplant. Patients will receive a combination of medications, including PTCy, Sirolimus, and a new drug called VIC-1911. The trial will determine the best dose of VIC-1911 that is both safe and effective. The treatment involves a series of steps, starting with a conditioning process using radiation, followed by the infusion of stem cells and administration of the study drugs.

Description

This study is designed to find the best dose of a new drug, VIC-1911, to prevent graft-versus-host disease (GVHD) and cancer relapse in patients receiving a stem cell transplant. The trial is divided into two phases. In Phase I, researchers will determine the safest dose of VIC-1911 by monitoring for any side effects. In Phase II, they will evaluate how well the treatment works in preventing GVHD and relapse compared to past results.

Patients will undergo a conditioning process with total body irradiation (TBI) before receiving stem cells from a matched donor. Cyclophosphamide will be given on days 3 and 4 after the transplant. Sirolimus will start on day 5 and continue for a year. VIC-1911 will be taken orally twice a day from day 5 to day 45, with doses adjusted based on safety and effectiveness.

The study aims to improve outcomes for patients undergoing stem cell transplants by reducing the risk of GVHD and cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with:
    • Acute leukemia in complete remission
    • Myelodysplasia with less than 5% blasts
    • Myeloproliferative neoplasm/myelofibrosis with less than 5% blasts
    • Chemosensitive Hodgkin or non-Hodgkin lymphoma
  • Aged 18 years or older
  • Good overall health with a performance status of 80% or higher
  • Adequate organ function, including:
    • Heart function with ejection fraction of 45% or more
    • Lung function with FEV1, FVC, and DLCO at 50% or more
    • Liver enzymes (AST and ALT) less than 2 times the normal limit
    • Total bilirubin less than 1.5 times the normal limit, unless approved for Gilbert syndrome
    • Kidney function with creatinine clearance of 50cc/min or more
    • No active or uncontrolled infections
    • Negative for HIV, HBV, and HCV
    • Ferritin level less than 2000 ng/ml
  • Able to take oral medication
  • Agree to use contraception during treatment and for 60 days after the last dose
  • Willing to provide written consent

Exclusion Criteria

  • High risk for complications with a score over 4 or unable to receive full radiation treatment
  • Planned maintenance therapy before day 75 post-transplant
  • History of allergic reactions to study drugs
  • Pregnant or breastfeeding women, as the drugs may harm the fetus or infant
  • Women and men of childbearing potential must agree to use contraception during treatment and for 60 days after the last dose
  • Women must have a negative pregnancy test within 28 days before starting the study

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