drugset / Trial / NCT03710772

Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT03710772 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well ibrutinib and rituximab given together with venetoclax and combination chemotherapy work in treating patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Drugs used in chemotherapy such as, cyclophosphamide, vincristine, doxorubicin, and dexamethasone, 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. Giving ibrutinib, rituximab, and venetoclax together with combination chemotherapy may work better in treating patients with mantle cell lymphoma.

Timeline

Start
2019-05-01
Primary completion
2027-03-22
Completion
2027-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Cytarabine Small molecule — Intravenous
Subject Dexamethasone Small molecule — Oral
Subject Doxorubicin Other / unclassified — Intravenous
Subject Ibrutinib Small molecule — Oral
Subject Methotrexate Small molecule — Intravenous
Subject Rituximab Monoclonal antibody — Intravenous
Subject Venetoclax Small molecule — Oral
Subject Vincristine Small molecule — Intravenous

Indications