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LymphomaPhase 2NCT00516412

Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

A Phase 2 study testing everolimus and molecular response by PCR in people with Lymphoma, run by Swiss Cancer Institute at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
everolimus and molecular response by PCR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
21 sitesin 3 countries
Study dates
Aug 2007to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • WHO performance status ≤ 2
  • Creatinine clearance ≥ 30mL/min
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
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  • 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

Who cannot join

  • 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:
  • Prior or concurrent hematological malignancies
  • Patients with prior solid organ tumors that required no treatment over the last 5 years and are currently free of disease are eligible
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  • Cardiovascular disease including any of the following:
  • NYHA class III or IV congestive heart failure
  • Unstable angina pectoris
  • Significant arrhythmia or arrhythmia requiring chronic treatment
  • Myocardial infarction in the last 3 months
  • Serious underlying medical condition which could impair the ability of the patient to participate in the trial including any of the following:
  • Uncontrolled diabetes mellitus
  • Gastric ulcers
  • Active autoimmune disease
  • Ongoing infection (e.g., HIV or hepatitis)
  • PRIOR CONCURRENT THERAPY:
  • Prior radiation where the indicator lesion(s) are in the irradiated field
  • Prior organ transplantation
  • Participation in another clinical trial within 30 days prior to study entry
  • Concurrent anticancer drugs/treatments or experimental medications
  • Other concurrent investigational therapy
  • Other concurrent chemotherapy, immunotherapy, or radiotherapy (including palliative radiotherapy)

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

Switzerland15 sites

  • Hirslanden Klinik Aarau

    Aarau, CH-5001

  • Kantonsspital Baden

    Baden, CH-5404

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

  • Inselspital Bern

    Bern, CH-3010

  • Kantonsspital Graubuenden

    Chur, CH-7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital Olten

    Olten, CH-4600

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Hopitaux Universitaires de Geneve

    Thonex-Geneve, CH-1226

  • Kantonsspital Winterthur

    Winterthur, CH-8400

  • Onkozentrum - Klinik im Park

    Zurich, 8002

  • Klinik Hirslanden

    Zurich, CH-8032

  • City Hospital Triemli

    Zurich, CH-8063

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

France4 sites

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Italy2 sites

  • University of Bologna Medical School

    Bologna, 40138

  • European Institute of Oncology

    Milan, 20141

Other trials in Italy

About this study

Official title: Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma

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.

Read the 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.

Conditions
Lymphoma
Being tested
everolimus, molecular response by PCR
Keywords
contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, recurrent mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • everolimusDrug

    Also called RAD001

    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.

  • 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

Study groups in NCT00516412
Study groupRoleWhat they receive
EverolimusExperimentalPatients 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.
Receives: Drug: everolimus; Genetic: molecular response by PCR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the efficacy and tolerability of everolimus

    Measured: Until treatment ends

Secondary outcomes (3)

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

    Measured: Until treament ends

  2. Investigation of immunoglobulin heavy chain variable gene somatic hypermutations

    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.

    Measured: Until treatment ends

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

    Measured: Until treatment ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJan 2010
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00516412
Sponsor's protocol ID
SAKK 36/06
Other IDs
EU-20749, 2007-001108-19
Status last verified
Sep 2015
First submitted
14 Aug 2007
Last updated
29 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22315486

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing everolimus and molecular response by PCR in people with Lymphoma, run by Swiss Cancer Institute at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Switzerland, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the efficacy and tolerability of everolimus (time frame: Until treatment ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00516412, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.

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