drugset / Trial / NCT02266888
B Cell Induction in Pediatric Lung Transplantation
Phase 2
Completed
45 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation in Children · collabRho Federal Systems Division, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has been studied in other types of solid organ transplants.
Timeline
- Start
- 2015-01-22
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Rituximab vs Placebo; p = 0.514; Hazard Ratio (HR) 0.673 (90% CI 0.248 to 1.826); Regression, Cox NCT02266888 ↗
paper There was no difference between treatment groups in time to the primary composite outcome endpoint PMID 34599540 ↗
Publications
- Results Sweet SC, Armstrong B, Blatter J, Chin H, Conrad C, Goldfarb S, Hayes D Jr, Heeger PS, Lyou V, Melicoff-Portillo E, Mohanakumar T, Odim J, Ravichandran R, Schecter M, Storch GA, Visner G, Williams NM, Danziger-Isakov L. CTOTC-08: A multicenter randomized controlled trial of rituximab induction to reduce antibody development and improve outcomes in pediatric lung transplant recipients. Am J Transplant. 2022 Jan;22(1):230-244. doi: 10.1111/ajt.16862. Epub 2021 Nov 5.
- Results Duncan-Park S, Dunphy C, Becker J, D'Urso C, Annunziato R, Blatter J, Conrad C, Goldfarb SB, Hayes D Jr, Melicoff E, Schecter M, Visner G, Armstrong B, Chin H, Kesler K, Williams NM, Odim JN, Sweet SC, Danziger-Isakov L, Shemesh E. Remote intervention engagement and outcomes in the Clinical Trials in Organ Transplantation in Children consortium multisite trial. Am J Transplant. 2021 Sep;21(9):3112-3122. doi: 10.1111/ajt.16567. Epub 2021 Apr 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
Indications
No indication recorded.