Study Stopped
Study was closed to accrual for safety related to the frequency of BK infections.
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)
3 other identifiers
interventional
20
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2010
CompletedFirst Posted
Study publicly available on registry
January 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedSeptember 6, 2023
August 1, 2023
3 years
January 7, 2010
January 23, 2018
August 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Event-free Survival
From the date of transplant with relapse/progression or death as censored events, up to 2 years
Overall Survival
From the date of transplant with death from any cause as a censored event, up to 2 years
Transplant-related Mortality (TRM)
At day 100
Study Arms (1)
Treatment (Rituximab and allogeneic HCT transplant)
EXPERIMENTALCONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab 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 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.
Interventions
Given IV
Given IV or PO
Given IV
Given IV
Stem cell transplant
Correlative studies
Undergo graft versus host disease prophylaxis/therapy
Given PO or IV
Given IV
Given IV
Undergo TBI
Undergo graft-versus-tumor induction therapy
Undergo immunosuppressive therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- R. Gregory Bociek, MD
- Organization
- University of Nebraska Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Bociek, MD
University of Nebraska
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2010
First Posted
January 8, 2010
Study Start
December 10, 2009
Primary Completion
December 19, 2012
Study Completion
October 10, 2017
Last Updated
September 6, 2023
Results First Posted
February 26, 2019
Record last verified: 2023-08