Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: everolimus; Genetic: molecular response by PCR

• Registration Number: NCT00516412
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Evaluation of the efficacy and tolerability of everolimus in patients with relapsed or therapy-resistant mantle cell lymphoma.

Secondary

* Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.

* Investigation of immunoglobulin heavy chain variable gene somatic hypermutations (Ig-V_H) in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma, in particular in regard to their frequency, mutation distribution pattern (antigen selected vs. at random), and the individually involved Ig-V_H families.

* Evaluation of a putative impact of Ig-V_H on clinical outcome.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Bone marrow and peripheral blood samples are collected periodically and analyzed for molecular response by PCR. Molecular studies are also performed on DNA level formalin-fixed paraffin-embedded tissue samples.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-15
• Primary Completion: 2010-01
• Study Completion: 2012-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	everolimus	Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Everolimus	molecular response by PCR	Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy and tolerability of everolimus	Until treatment ends

Secondary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.	Until treament ends
Evaluation of a putative impact of Ig-V_H on clinical outcome.	Until treatment ends
Investigation of immunoglobulin heavy chain variable gene somatic hypermutations	Until treatment ends	Investigation of immunoglobulin heavy chain variable gene somatic hypermutations (Ig-V_H) in classical mantle cell lymphoma as compared to blastoid mantle cell lymphoma, in particular in regard to their frequency, mutation distribution pattern (antigen selected vs. at random), and the individually involved Ig-V_H families.

Trial Locations

Locations (21)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland

Universitaetsspital-Basel; 🇨🇭 Basel, Switzerland

Kantonsspital Olten; 🇨🇭 Olten, Switzerland

Onkozentrum - Klinik im Park; 🇨🇭 Zurich, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

European Institute of Oncology; 🇮🇹 Milan, Italy

CHU de Grenoble - Hopital de la Tronche; 🇫🇷 Grenoble, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

Inselspital Bern; 🇨🇭 Bern, Switzerland

University of Bologna Medical School; 🇮🇹 Bologna, Italy

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Hirslanden Klinik Aarau; 🇨🇭 Aarau, Switzerland

Istituto Oncologico della Svizzera Italiana; 🇨🇭 Bellinzona, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Hopitaux Universitaires de Geneve; 🇨🇭 Thonex-Geneve, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland