Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

This study is currently recruiting participants.
Verified July 2012 by Mayo Clinic

First Received on February 23, 2010.  
Last Updated on July 23, 2012  
History of Changes
This Clinical Trial Sponsored By: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01075321
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
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
Drug: everolimus
Drug: lenalidomide
Other: laboratory biomarker analysis
Genetic: polymorphism analysis
Other: immunohistochemistry staining method
Genetic: microarray analysis
Genetic: fluorescence in situ hybridization
Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial of the mTor Inhibitor RAD001 (Everolimus) in Combination With Lenalidomide (Revlimid) for Patients With Relapsed or Refractory Lymphoid Malignancy

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Drug Information available for:
Sirolimus
Everolimus
Temsirolimus
Lenalidomide

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures For Clinical Trial:

  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Proportion of responses [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Survival time [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 59
Study Start Date: January 2011
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Arm I

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.
Drug: everolimus

Given orally
Other Names:
  • 42-O-(2-hydroxy)ethyl rapamycin
  • Afinitor
  • RAD001

Drug: lenalidomide

Given orally
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid

Other: laboratory biomarker analysis

Correlative studies

Genetic: polymorphism analysis

Correlative studies

Other: immunohistochemistry staining method

Optional correlative studies
Other Name: immunohistochemistry

Genetic: microarray analysis

Optional correlative studies
Other Name: gene expression profiling

Genetic: fluorescence in situ hybridization

Optional correlative studies
Other Name: fluorescence in situ hybridization (FISH)

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish the maximum tolerated dose of RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase I) II. To assess tumor response to RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase II)

SECONDARY OBJECTIVES:

I. To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure of subjects receiving RAD001 and lenalidomide.

II. To describe the adverse event profile (using CTCAE CTEP Active Version) of RAD001 and lenalidomide.

OUTLINE: Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment re

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