NCT00516412

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Aug 2007

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

August 14, 2007

Last Update Submit

September 28, 2015

Conditions

Lymphoma

Keywords

contiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the efficacy and tolerability of everolimus

    Until treatment ends

Secondary Outcomes (3)

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

    Until treament ends

  • Investigation of immunoglobulin heavy chain variable gene somatic hypermutations

    Until treatment ends

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

    Until treatment ends

Study Arms (1)

Everolimus

EXPERIMENTAL

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.

Drug: everolimusGenetic: molecular response by PCR

Interventions

everolimusDRUG

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.

Also known as: RAD001
Everolimus
molecular response by PCRGENETIC

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

Everolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed relapsed or chemotherapy/immunotherapy-resistant mantle cell lymphoma
  • No more than 3 lines of prior systemic treatment
  • At least one measurable lesion ≥ 15 mm in its greatest transverse diameter by CT scan

You may not qualify if:

  • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningosis)
  • Newly diagnosed mantle cell lymphoma
  • Patients suitable for intensive treatment (e.g., hyperfractionated cyclophosphamide, vincristine, doxorubicin hydrochloride and dexamethasone with high-dose methotrexate and cytarabine \[HyperCVAD\])
  • PATIENT CHARACTERISTICS:
  • WHO performance status ≤ 2
  • Creatinine clearance ≥ 30mL/min
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • AST and ALT ≤ 2 times ULN
  • Neutrophils ≥ 1,500/mm³ (≥ 1,000/mm³ with marrow infiltration)
  • Thrombocytes ≥ 100,000/mm³ (≥ 75,000/mm³ in case of bone marrow infiltration)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after study participation
  • Prior or concurrent hematological malignancies
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

University of Bologna Medical School

Bologna, 40138, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Hirslanden Klinik Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Hopitaux Universitaires de Geneve

Thonex-Geneve, CH-1226, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Onkozentrum - Klinik im Park

Zurich, 8002, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8032, Switzerland

Location

City Hospital Triemli

Zurich, CH-8063, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

  • Renner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. doi: 10.3324/haematol.2011.053173. Epub 2012 Feb 7.

    PMID: 22315486RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Christoph Renner, MD

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2007

First Posted

August 15, 2007

Study Start

August 1, 2007

Primary Completion

January 1, 2010

Study Completion

August 1, 2012

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

FR(4)CH(15)IT(2)