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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of the efficacy and tolerability of everolimus
Until treatment ends
Christoph Renner, MD