A Phase I and Feasibility Study of Everolimus (RAD001) Plus R-CHOP for New Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

NCT01334502 Phase 1 COMPLETED

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Giving everolimus together with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and the best dose of everolimus when given together with rituximab and combination chemotherapy in treating patients with newly diagnosed untreated diffuse large B-cell lymphoma.

Details

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 1
Status	COMPLETED
Enrolment	26
Start date	2012-03
Completion	2017-08

Conditions

• Lymphoma

Interventions

• rituximab
• cyclophosphamide
• doxorubicin hydrochloride
• everolimus
• prednisone
• vincristine sulfate

Primary outcomes

• MTD of everolimus in combination with R-CHOP — Up to 15 months post registration to Phase I portion of the study
• Adverse events profile — Up to 15 months post registration to Phase I portion of the study
• Toxicity profile — Up to 15 months post registration to Phase I portion of the study
• Proportion of patients who have a significant toxicity — Up to 2.5 years post registration to Feasibility portion of the study

Countries

United States