RECRUITING

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

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Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaGraft Versus Host DiseaseMyelodysplastic SyndromeMyeloproliferative Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-16
Study Completion:2028-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06815003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented informed consent of the participant and/or legally authorized representative
  2. * Assent, when appropriate, will be obtained per institutional guidelines
  3. * Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  4. * If unavailable, exceptions may be granted with study principal investigator (PI) approval
  5. * Age: ≥ 18 and ≤ 80 years old
  6. * Note: Patients \> 70 years of age must have Karnofsky performance status ≥ 80 and hematopoietic cell transplantation-comorbidity index (HCT-CI) ≤ 2
  7. * Karnofsky performance status ≥ 70%
  8. * Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8/8 match related/unrelated donor (A, B, C, DR by high resolution typing)
  9. * Acute Leukemias (acute myeloid leukemia \[AML\] or acute lymphoblastic leukemia \[ALL\]) in complete remission with bone marrow (BM) blast of \< 5%
  10. * Myelodysplastic syndrome (blast \< 10%)
  11. * Myeloproliferative neoplasm (MPN) other than myelofibrosis (MF) needing HCT
  12. * Chronic myelomonocytic leukemia (CMML)
  13. * Hemoglobin ≥ 9g/dL (within 30 days prior to day 1 of protocol therapy)
  14. * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
  15. * Total bilirubin ≤ 2.0 mg/dL (unless has Gilbert's disease) AND serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \< 5 times the upper limit of normal (ULN) (within 30 days prior to day 1 of protocol therapy)
  16. * Aspartate aminotransferase (AST) =\< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)
  17. * Alanine aminotransferase (ALT) =\< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)
  18. * Creatinine clearance of ≤ 1.5 mg/dL or ≥ 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy)
  19. * Left ventricular ejection fraction (LVEF) ≥ 50%
  20. * Note: To be performed within 28 days prior to day 1 of protocol therapy
  21. * IF ABLE TO PERFORM PULMONARY FUNCTION TESTS: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)
  22. * Note To be performed within 28 days prior to day 1 of protocol therapy
  23. * IF UNABLE TO PERFORM PULMONARY FUNCTION TESTS: Oxygen (O2) saturation \> 92% on room air
  24. * Note To be performed within 28 days prior to day 1 of protocol therapy
  25. * Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 30 days prior to day 1 of protocol therapy)
  26. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  27. * Tuberculosis test (within 30 days prior to day 1 of protocol therapy)
  28. * Patients with positive tuberculosis (TB) test results will have infectious disease (ID) evaluation and post HCT therapy with isoniazid (INH) for 6 months with ID follow up. Vaccinated patients will need negative chest X-ray results
  29. * Meets other institutional and federal requirements for infectious disease titer requirements
  30. * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  31. * Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)
  32. * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  33. * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
  34. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
  1. * Prior allogeneic HCT
  2. * Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
  3. * Note: Conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy with agents listed are not excluded
  4. * Other investigational drugs for GVHD prophylaxis
  5. * Herbal medications
  6. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
  7. * Clinically significant uncontrolled illness
  8. * Active infection not responding to antibiotics
  9. * Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  10. * Females only: Pregnant or breastfeeding
  11. * Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
  12. * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  13. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Contacts and Locations

Principal Investigator

Monzr M Al Malki
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

  • Monzr M Al Malki, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16
Study Completion Date2028-10-15

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2028-10-15

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Graft Versus Host Disease
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm