Study:
A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT)
Rationale:
Drugs used in chemotherapy such as cyclophosphamide, prednisone, and
methylprednisolone use different ways to stop cancer cells from dividing so they stop
growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either
kill them or deliver cancer-killing substances to them without harming normal cells.
Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be
effective in treating lymphoproliferative disease following organ transplantation.
Purpose:
Phase II trial to study the effectiveness of combining cyclophosphamide and either
prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr
virus-positive lymphoproliferative disease following organ transplantation.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Lymphoproliferative Disorder |
Biological: rituximab
Drug: cyclophosphamide
Drug: methylprednisolone
Drug: prednisone |
Phase 2 |
Verified by
Children`s Oncology Group
March, 2013
Sponsored by: Children`s Oncology Group
Information provided by: Children`s Oncology Group
ClinicalTrials.gov identifier: NCT00066469
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Thomas G. Gross, MD, PhD., Study Chair