RECRUITING

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

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

The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination. Participants will: * Receive the standard or new drug combination after transplant * Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients * Take surveys about physical and emotional well-being * Give blood and stool samples.

Official Title

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Quick Facts

Study Start:2025-07
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06859424

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 66 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
  2. 2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
  3. 3. Subjects with a prior allogeneic transplant
  4. 4. Subjects with an autologous transplant within the past 3 months
  5. 5. Subjects who are breastfeeding or pregnant
  6. 6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
  7. 7. Concurrent enrollment on a GVHD prevention clinical trial
  8. 8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant
  9. 9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.

Contacts and Locations

Study Contact

Sarah Smith, RN
CONTACT
7634065397
accelerate@nmdp.org

Study Locations (Sites)

MD Anderson
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Center for International Blood and Marrow Transplant Research

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 Date2025-07
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-07
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • ACCELERATE
  • ACCEL-001
  • ACCEL-002

Additional Relevant MeSH Terms

  • AML (Acute Myelogenous Leukemia)
  • Acute Lymphoid Leukemia (ALL)
  • Acute Leukemia (Category)
  • MDS (Myelodysplastic Syndrome)
  • CML (Chronic Myelogenous Leukemia)
  • CLL (Chronic Lymphocytic Leukemia)
  • Prolymphocyctic Leukemia
  • Chronic Myelomonocytic Leukemia (CMML)
  • Myeloproliferative Neoplasm (MPN)
  • Lymphoma
  • Myelofibrosis