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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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



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


- 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.

Inclusion Criteria


Inclusion criteria:

- 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

Exclusion criteria:

- 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])


Inclusion criteria:

- 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

Exclusion criteria:

- 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

- 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)


Exclusion criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the efficacy and tolerability of everolimus

Outcome Time Frame:

Until treatment ends

Safety Issue:


Principal Investigator

Christoph Renner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UniversitaetsSpital Zuerich


Switzerland: Swissmedic

Study ID:

SAKK 36/06



Start Date:

August 2007

Completion Date:

August 2012

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Mantle-Cell