Clinical trial NCT01075321
Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-cell Lymphoma Post-transplant Lymphoproliferative Disorder Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Splenic Marginal Zone Lymphoma Waldenstrom Macroglobulinemia
Sponsor: Mayo Clinic
Start date: 2011-01-10; Completion date: 2020-02-13
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.

Detailed description:
PRIMARY OBJECTIVES:

I.Phase I: To establish the maximum tolerated dose of EVEROLIMUS and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma.

II. Phase II: To assess tumor response to EVEROLIMUS and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma.

SECONDARY OBJECTIVES:

I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of subjects receiving EVEROLIMUS and lenalidomide.

II. To describe the adverse event profile (using CTCAE CTEP Version 4.0) of EVEROLIMUS and lenalidomide.

OUTLINE: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: everolimus intervention 2: lenalidomide intervention 3: laboratory biomarker analysis intervention 4: polymorphism analysis intervention 5: immunohistochemistry staining method intervention 6: microarray analysis intervention 7: fluorescence in situ hybridization
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Optional correlative studies intervention 6: Optional correlative studies intervention 7: Optional correlative studies

Protocol documents: