Graft Versus Host Disease Clinical Trial
Official title:
Rituximab For Prevention Of Acute Graft-Versus-Host Disease (GVHD) After Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (HCT)
| Verified date | August 2023 |
| Source | University of Nebraska |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | October 10, 2017 |
| Est. primary completion date | December 19, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML) in accelerated phase or blast crisis, chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL), myelodysplastic syndromes (MDS) (intermediate-2 or high-risk disease by International Pelvic Pain Society [IPPS]) - Patients with AML, ALL, or MDS scheduled for myeloablative conditioning should have =< 10% blasts in bone marrow or peripheral blood at the start of conditioning - Patients with AML, ALL, or CML scheduled for reduced intensity conditioning or non-myeloablative conditioning should be in complete morphologic remission at the start of conditioning (residual disease by flow cytometry or cytogenetics and/or incomplete recovery of neutrophil or platelet count are acceptable) - Patients with CLL or NHL scheduled for reduced intensity or non-myeloablative conditioning should have no evidence of bulky disease (> 50% bone marrow involvement or masses > 10 cm) at the start of conditioning - Fulfills all pulmonary, cardiac, renal, and hepatic criteria for standard-of-care matched unrelated donor (MUD) allogeneic HCT - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after stem cell transplantation - Adequately matched unrelated donor available - Written informed consent; written informed consent of the unrelated donor is required to participate in the optional studies Exclusion Criteria: - Patient or donor infected with human immunodeficiency virus (HIV) - Patient or donor with history of hepatitis B or C and/or positive serology consistent with previous hepatitis B or C infection (patients and/or donor who received Hepatitis B vaccination are acceptable) - Patient or donor with active hepatitis B or C and/or detectable viral ribonucleic acid (RNA) - More than 20,000 circulating CD20+ cells/uL - Treatment with rituximab for any reason in the 12 months preceding HCT - Patient scheduled for cord blood transplantation - Presence of active uncontrolled infection at start of conditioning - Presence of active central nervous system (CNS) disease (history of adequately treated CNS disease is acceptable) - Presence of uncontrolled psychiatric disorder - Patient unable to give informed consent - Unrelated donor products received from the Deutsche Knochenmarkspenderdatei (DKMS) Registry are not eligible for the optional study |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nebraska | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Grades II-IV Acute GVHD | Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria. | At day 100 | |
| Secondary | Event-free Survival | Estimated using Kaplan-Meier estimator. | From the date of transplant with relapse/progression or death as censored events, up to 2 years | |
| Secondary | Overall Survival | Estimated using Kaplan-Meier estimator. | From the date of transplant with death from any cause as a censored event, up to 2 years | |
| Secondary | Transplant-related Mortality (TRM) | Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage. | At day 100 |
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