CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
rituximab +1 morebiological
Likely dose
Temsirolimus 25 mg IV (once weekly, typical) and rituximab 375 mg/m² IVAI-extracted
Key inclusion· 6
  • Histologically confirmed mantle cell lymphoma that is relapsed, refractory, or stable after prior treatment
  • Tumor must express cyclin D1 by immunohistochemistry OR harbor t(11;14) translocation by FISH or cytogenetics
  • Measurable disease: lymph node/tumor ≥2 cm on imaging, OR palpable splenic enlargement ≥3 cm below left costal margin, OR malignant lymphocytosis (absolute lymphocyte count ≥5000 with monoclonal confirmation by flow cytometry)
  • No known CNS involvement (parenchymal mass or leptomeningeal)
Key exclusion· 8
  • Prior mTOR inhibitor treatment is disqualifying
  • No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
  • No ongoing or active infection
  • No known HIV positivity

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00109967
NCT00109967Phase 2Completed

A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

National Cancer Institute (NCI)·interventional·Posted May 4, 2005·Updated Apr 17, 2014

In Brief

A Phase 2 clinical trial evaluating rituximab and temsirolimus for Recurrent Mantle Cell Lymphoma. Completed, enrolled 71 participants across 195 sites.

Detailed Summary

This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CCI-779 together with rituximab may kill more cancer cells

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2005
Enrollment StartMay 1, 2005
Primary CompletionSep 1, 2009
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 21.2 years ago

Interventions

rituximabbiological

375 mg/m\^2 Given IV

temsirolimusdrug

25 mg given IV