drugset / Trial / NCT00186628
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Phase 2
Completed
36 enrolled
Stanford University
National Cancer Institute (NCI) · collabThe Leukemia and Lymphoma Society · collab
NaSingle-groupOpen-labelTreatment
Summary
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Timeline
- Start
- 2005-06
- Primary completion
- 2010-11
- Completion
- 2010-12
Publications
- Background Filipovich 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.
- Results Arai 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Acetaminophen | Small molecule | 650 mg | Oral |
| Background | Cyclosporine | Peptide | 6.25 mg/kg | Oral |
| Background | Diphenhydramine | Unknown | 50 mg | Intravenous |
| Background | Granisetron | Other / unclassified | 1 mg | Oral |
| Background | Hydrocortisone | Other / unclassified | 100 mg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 1 mg/kg | — |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |