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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

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.

Conditions

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)Acute Leukemia (Category)MDS (Myelodysplastic Syndrome)CML (Chronic Myelogenous Leukemia)CLL (Chronic Lymphocytic Leukemia)Prolymphocyctic LeukemiaChronic Myelomonocytic Leukemia (CMML)Myeloproliferative Neoplasm (MPN)LymphomaMyelofibrosis
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Related Conditions:

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

Study Overview

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Study Details

Study overview

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.

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

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

Condition
AML (Acute Myelogenous Leukemia)
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson, Houston, Texas, United States, 77030

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
  • 2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
  • 3. Subjects with a prior allogeneic transplant
  • 4. Subjects with an autologous transplant within the past 3 months
  • 5. Subjects who are breastfeeding or pregnant
  • 6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
  • 7. Concurrent enrollment on a GVHD prevention clinical trial
  • 8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant
  • 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.

Ages Eligible for Study

18 Years to 66 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Center for International Blood and Marrow Transplant Research,

Study Record Dates

2028-06