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NCT00109967 · ClinicalTrials.gov registry record · Phase 2

CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
71
Enrollment target

NCT00109967: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00109967 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00109967, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target

Study 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

Primary Outcome

Complete Response (CR) - Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. Partial Response (PR) requires a \>=50% decrease in sum of the products of the greatest dimension (SPD) of the six largest dominant nodes or nodal masses. Overall Response Rate (ORR) - The number of patients who achieve a CR or PR divided by the total number of evaluable patients. We report the Overall Response Rate here.

Interventions

  • BIOLOGICAL rituximab
  • DRUG temsirolimus

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2005-05
Est. Completion 2012-03
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00109967 record still lists

NCT00109967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which rituximab is the first listed.

NCT00109967 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00109967 about?

NCT00109967 is a clinical study titled "CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma". 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 stopp...

What is the current status of trial NCT00109967?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2005-05. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00109967?

The interventions under investigation include: rituximab (BIOLOGICAL), temsirolimus (DRUG).

Who is sponsoring clinical trial NCT00109967?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00109967's enrollment target sits among peer trials

71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00109967, the US trial registry maintained by the National Library of Medicine. NCT00109967 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.