Clinical Trials Directory

Trials / Terminated

TerminatedNCT01044745

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer

Rituximab For Prevention Of Acute Graft-Versus-Host Disease (GVHD) After Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (HCT)

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
19 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I. To determine the incidence of grade II-IV acute GVHD at day 100 after matched unrelated donor allogeneic hematopoietic cell transplantation (HCT) when incorporating rituximab in the conditioning regimen. SECONDARY OBJECTIVES: I. To determine the day 100 transplant related mortality after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen. II. To determine overall survival (OS) and disease-free survival (DFS) after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen. III. To determine the cumulative incidence of infectious complications at day 100 after matched unrelated donor HCT when incorporating rituximab in the conditioning regimen. IV. To determine the effect of rituximab addition to the conditioning regimen on recovery of T regulatory (T-reg) cells, and to determine the effect of T-cell, including T-reg, number in the stem cell product and at day 30 on the incidence of grade II-IV acute GVHD (aGVHD) and the cumulative infectious complications at day 100. V. To determine the effect of rituximab addition to the conditioning regimen on antigen presenting myeloid cell recovery, and to determine the effect of dendritic cell subset DC1, DC2 and myeloid-derived suppressor cells (MDSC), number in the stem cell graft and at day +30 on the incidence of acute GVHD grade II-IV and the cumulative incidence of infectious complications at day 100. OUTLINE: CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and total-body irradiation (TBI); targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab intravenously (IV) on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then orally (PO) beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Patients are followed up periodically for 100 days after transplant.

Conditions

Interventions

TypeNameDescription
DRUGrituximabGiven IV
DRUGmycophenolate mofetilGiven IV or PO
DRUGtacrolimusGiven IV
DRUGanti-thymocyte globulinGiven IV
PROCEDUREallogeneic hematopoietic stem cell transplantationStem cell transplant
OTHERlaboratory biomarker analysisCorrelative studies
BIOLOGICALgraft versus host disease prophylaxis/therapyUndergo graft versus host disease prophylaxis/therapy
DRUGcyclophosphamideGiven PO or IV
DRUGfludarabine phosphateGiven IV
DRUGbusulfanGiven IV
RADIATIONtotal-body irradiationUndergo TBI
BIOLOGICALgraft-versus-tumor induction therapyUndergo graft-versus-tumor induction therapy
BIOLOGICALimmunosuppressive therapyUndergo immunosuppressive therapy

Timeline

Start date
2009-12-10
Primary completion
2012-12-19
Completion
2017-10-10
First posted
2010-01-08
Last updated
2023-09-06
Results posted
2019-02-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01044745. Inclusion in this directory is not an endorsement.