drugset / Trial / NCT03864419

Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in Uganda

NCT03864419

Phase 1 Terminated 18 enrolled Fred Hutchinson Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies how well rituximab hyaluronidase and combination chemotherapy work in treating patients in Uganda with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma herpesvirus associated multicentric Castleman disease. Rituximab hyaluronidase is a combination of rituximab and hyaluronidase. Rituximab binds to a molecule called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Hyaluronidase allows rituximab to be given by injection under the skin. Giving rituximab and hyaluronidase by injection under the skin is faster than giving rituximab alone by infusion into the blood. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, methotrexate, etoposide, doxorubicin, and prednisone work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. While rituximab has a clear survival benefit in patients within developed countries, differences in supportive care and infectious co-morbidities require special attention. Giving rituximab hyaluronidase alone or in combination with chemotherapy may work better in treating patients with Burkitt lymphoma, diffuse large B-cell lymphoma, or Kaposi sarcoma herpesvirus associated multicentric Castleman disease compared to chemotherapy alone in Uganda.

Timeline

Start
2019-10-24
Primary completion
2023-07-26
Completion
2023-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 700 mg Intravenous
Subject Rituximab Monoclonal antibody 1400 mg Intravenous
Subject rHuPH20 Protein / enzyme biologic Subcutaneous
Background Cyclophosphamide Other / unclassified Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Etoposide Small molecule Intravenous
Background Methotrexate Small molecule Intravenous
Background Prednisone Other / unclassified Oral
Background Vincristine Small molecule Intravenous