Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma
Status:
Completed
Trial end date:
2017-09-08
Target enrollment:
Participant gender:
Summary
This is a multicenter, open label, single arm, phase I/II study. There will be no placebo
usage within this trial.
Phase I:
Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen
of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle
cell lymphoma.
Phase II:
Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT
dose Secondary: To determine the complete remission rate, progression free survival rate and
overall survival rate and to investigate safety and tolerability of BERT.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Georg Hess, MD
Collaborators:
Mundipharma Pte Ltd. Wyeth is now a wholly owned subsidiary of Pfizer