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NCT01381692 · ClinicalTrials.gov registry record · Phase 1
Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01381692: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01381692 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381692, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth in difference 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. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether bortezomib, rituximab, and dexamethasone are more effective with temsirolimus in treating non-Hodgkin lymphoma.
Primary Outcome
Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- BIOLOGICAL Rituximab
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-07-20 |
| Est. Completion | 2021-09-01 |
| Phase | Phase 1 |
What the finished NCT01381692 record still lists
NCT01381692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01381692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381692 about?
NCT01381692 is a clinical study titled "Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma". This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Walde...
What is the current status of trial NCT01381692?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-07-20. Estimated completion is 2021-09-01.
What interventions are being tested in trial NCT01381692?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Rituximab (BIOLOGICAL), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT01381692?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01381692's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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