Trial intelligence / Profile preview

CCI-779 in Relapsed/Refractory Mantle Cell Lymphoma

NCT00033267Phase 2

Key facts

Status
Completed
Start
Apr 2002
Primary completion
Feb 2006
Countries
1
Sponsor
National Cancer Institute
Modality
Small Molecules
Conditions
mantle cell lymphoma (MCL)
01

Overview

Phase 2, open-label, single-arm trial of temsirolimus in mantle cell lymphoma (MCL), sponsored by National Cancer Institute. Primary endpoint: Objective Response Rate at 24 weeks. Started Apr 2002; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Treatment

    Temsirolimus IV weekly

03

Who it enrols

Patients with histologically confirmed relapsed or refractory mantle cell lymphoma, measurable disease, ECOG 0-2, and adequate organ function.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Time to Progression

  • Overall Survival

  • Progression-Free Survival

  • Duration of Response

  • Toxic Effects

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