NCT00436618

Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Phase II Trial of Everolimus (RAD001) in Relapsed/Refractory Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. PURPOSE: This phase II trial is studying the side effects and how well everolimus works in treating patients with lymphoma that has relapsed or not responded to previous treatment.

Detailed description

OBJECTIVES: Primary * Assess the tumor response in patients with relapsed or refractory indolent non-Hodgkin lymphoma (closed to accrual as of 8/18/08), aggressive non-Hodgkin's lymphoma (closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma), or uncommon lymphoma (closed to accrual as of 9/2/08), including Hodgkin's lymphoma, treated with everolimus. Secondary * Evaluate overall survival, progression-free survival, and time to disease progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive lymphoma \[closed to accrual as of 2/7/08 except for diffuse large B cell lymphoma, grade III follicular lymphoma, or transformed lymphoma\] vs indolent lymphoma \[closed to accrual as of 8/18/08\] vs uncommon lymphoma \[closed to accrual as of 9/2/08\]). Patient receive oral everolimus daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tissue collection at baseline and periodically during study treatment for translational research studies. Blood and tissue samples are analyzed for biomarkers to study the effect of everolimus on lymphoma. After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

• Leukemia
• Lymphoma
• Lymphoproliferative Disorder

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-12-01
• Completion: 2019-10-09
• First posted: 2007-02-19
• Last updated: 2019-10-22
• Results posted: 2013-07-30

Locations

3 sites across 1 country: United States