Clinical trial · Interventional
Rituximab for Prevention of Chronic GVHD
A Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft-vs.-Host Disease After Allogeneic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to determine if administration of rituximab after allogeneic stem cell transplantation can reduce the incidence of chronic GVHD. Chronic GVHD is a medical condition that can occur after bone marrow or stem cells are transplanted form one individual to another. After the transplant, the donor immune system may recognize the recipient body as foreign and may attempt to "reject" the body. Rituximab is a drug that interferes with the immune system function by specifically targeting B cells and killing them.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 375 mg/m2 RRituximab | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of Clinician-diagnosed Chronic GVHD at One and Two Years
- timeFrame
- by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
Secondary outcomes (3)
- measure
- Incidence of Grade 3 or Higher Infectious Complications
- timeFrame
- by 1 and 2 years after peripheral blood stem cell (PBSC) infusion
- measure
- Incidence of Relapse or Progression of Disease
- timeFrame
- by 4 years after peripheral blood stem cell (PBSC) infusion
- description
- Percentage of participants with relapsed disease by year 4 post transplant.
- measure
- Incidence of Adverse Hematological Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation * Peripheral blood stem cells must have been used as the stem cell source * Patients must have received transplantation from donors who are identical at 6 HLA loci, or mismatched at no more than 1 locus. * Patients who have undergone a non-myeloablative stem cell transplant must have \> 80% donor hematopoiesis within 30 days of study enrollment * 18 years of age or older * Performance Status 0-2 * Life expectancy of \> 100 days * Subjects with CLL are eligible, if there is no more than 20% residual leukemia in the bone marrow at the time of study entry Exclusion Criteria: * Evidence of relapsed or residual malignancy within 30 days of trial entry * Highly aggressive B cell malignancy, such as Burkitt's lymphoma or Burkitt's-like lymphoma * Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow * Evidence of any active uncontrolled infection, or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV * Evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing Stage I cutaneous acute GVHD * GVHD with chronic features diagnosed prior to day +100 or prior to enrollment * Participation in a clinical trial evaluating another preventative strategy for chronic GVHD, or ongoing participation in a clinical trial for therapy of acute GVHD * No Donor Lymphocyte Infusion (DLI) prior to day 100 and not plans for a DLI in the upcoming 30 days * Heart failure uncontrolled by medications * Pregnancy or lactation
References
Publications (1)
- DERIVEDCutler C, Kim HT, Bindra B, Sarantopoulos S, Ho VT, Chen YB, Rosenblatt J, McDonough S, Watanaboonyongcharoen P, Armand P, Koreth J, Glotzbecker B, Alyea E, Blazar BR, Soiffer RJ, Ritz J, Antin JH. Rituximab prophylaxis prevents corticosteroid-requiring chronic GVHD after allogeneic peripheral blood stem cell transplantation: results of a phase 2 trial. Blood. 2013 Aug 22;122(8):1510-7. doi: 10.1182/blood-2013-04-495895. Epub 2013 Jul 16. PMID 23861248