A Phase I and Feasibility Study of Everolimus (RAD001) Plus R-CHOP for New Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
- To establish the maximum-tolerated dose (MTD) of everolimus in combination with R-CHOP
(rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and
- To assess the feasibility of everolimus in combination with standard R-CHOP
chemotherapy in patients with newly diagnosed diffuse large B-cell lymphoma.
- To describe the toxicities associated with everolimus in combination with R-CHOP
- To further describe the toxicities associated with everolimus in combination with
- To assess the rate of event-free survival (EFS) at 12 months for diffuse large B-cell
lymphoma patients treated with everolimus in combination with R-CHOP chemotherapy.
- To evaluate overall response rate, complete response rate, duration of response, EFS,
overall survival, and progression-free survival for patients treated with everolimus in
combination with R-CHOP chemotherapy.
- To profile gene expression using immunohistochemistry and categorize patients as
germinal-center B-cell-like (GBC) vs activated B-cell-like (ABC) vs unclassified
lymphoma subtype. (exploratory)
- To determine whether previously identified predictive markers in large cell lymphoma
remain valid with the addition of everolimus to R-CHOP chemotherapy. (exploratory)
OUTLINE: This is a multicenter, dose-escalation study of everolimus followed by a
feasability expanded-cohort study.
Patients receive everolimus orally (PO) once daily (QD) on days 1-10 or 1-14; rituximab IV,
cyclophosphamide IV, doxorubicin hydrochloride IV over 15-60 minutes, and vincristine
sulfate IV on day 1; and prednisone PO QD on days 1-5. Treatment repeats every 21 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity.
Tumor biopsies are collected for laboratory studies and patients may undergo blood and
needle biopsy sample collection for correlative studies.
After completion of study treatment, patients are followed up every 3-6 months for up to 5
Masking: Open Label, Primary Purpose: Treatment
MTD of everolimus in combination with R-CHOP
Patrick Johnston, MD, PhD
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|