Clinical trial · Interventional
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation
NCT00186628CI-TRIAL-00030547completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Mast-Cell | Mast Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| Mantle-cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Anti-thymoglobulin, rabbit (ATG, rabbit ATG) | Drug | — | UNRESOLVED |
| Cyclosporine | Drug | — | UNRESOLVED |
| Diphenhydramine | Drug | — | UNRESOLVED |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Granisetron | Drug | — | UNRESOLVED |
| Hydrocortisone | Drug | — | UNRESOLVED |
| Mycophenylate mofetil | Drug | — | UNRESOLVED |
| Rituximab | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prophylactic Rituximab
- description
- Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD)
- interventionNames
- Procedure: Total lymphoid irradiation
- Drug: Rituximab
- Drug: Anti-thymoglobulin, rabbit (ATG, rabbit ATG)
- Drug: Cyclosporine
- Drug: Mycophenylate mofetil
- Drug: Filgrastim
- Drug: Granisetron
- Drug: Solumedrol
- Drug: Acetaminophen
- Drug: Diphenhydramine
- Drug: Hydrocortisone
Primary outcomes (1)
- measure
- Chronic Graft-vs-Host Disease (cGvHD)
- timeFrame
- 4 years
- description
- The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
Recipient Inclusion Criteria: * Between 18 and 76 years of age * Chronic lymphocytic leukemia (CLL): * Unmutated IgG VH gene status * Mutated IgG VH genes (\> 2% nucleotide change compared to somatic sequence) * Complete remission benefit most from allogeneic hematopoietic stem cell transplant (HSCT). (Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.) * Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from allogeneic HSCT. * Adequate renal (Cr \< 2.4 mg/dL) and hepatic (Bilirubin \< 3.0 mg/dL, Aspartate aminotransferase (AST) \< 100 IU) function. * Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. * All subjects must provide written informed consent Donor Inclusion Criteria: * Genotypically or phenotypically human leukocyte antigen (HLA)-identical. * Age \< 76 unless cleared by institutional PI * Capable of giving written, informed consent. * Must consent to peripheral blood stem cell (PBSC) mobilization with G-CSF and apheresis Recipient Exclusion Criteria: * Recipient has a 9 of 10 or 10 of 10 HLA identical donor (high resolution molecular genotyping at HLA A, B, C and DrB1, and DQ) * Pregnancy * Lactating * Serious uncontrolled infection * HIV seropositivity * Hepatitis B or C seropositivity * Cardiac function: ejection fraction \< 40% or uncontrolled cardiac failure * Pulmonary: Diffusing capacity - carbon monoxide (DLCO) \< 50% predicted * Liver function abnormalities: elevation of bilirubin to ≥ 3 mg/dL and/or AST \> 100 * Renal: creatinine \> 2.4 * Karnofsky performance score ≤ 60% * Patients with poorly controlled hypertension (systolic blood pressure \> 150 or diastolic blood pressure \> 90 repeatedly). * Known life-threatening hypersensitivity to rituximab or other anti-B cell antibodies. * Inability to comply with the allogeneic transplant treatment. * Uncontrolled central nervous system (CNS) involvement with disease Donor Exclusion Criteria: * Identical twin to subject * Contra-indication to subcutaneous G-CSF at a dose of 16 mg/kg/d for 5 consecutive days * Serious medical or psychological illness * Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers. * HIV seropositivity
References
Publications (2)
- BACKGROUNDFilipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004. PMID 16338616
- RESULTArai S, Sahaf B, Narasimhan B, Chen GL, Jones CD, Lowsky R, Shizuru JA, Johnston LJ, Laport GG, Weng WK, Benjamin JE, Schaenman J, Brown J, Ramirez J, Zehnder JL, Negrin RS, Miklos DB. Prophylactic rituximab after allogeneic transplantation decreases B-cell alloimmunity with low chronic GVHD incidence. Blood. 2012 Jun 21;119(25):6145-54. doi: 10.1182/blood-2011-12-395970. Epub 2012 May 4. PMID 22563089