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NCT00151320 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT00151320: Completed Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT00151320 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00151320, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
Primary Objective: To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL) Secondary Objectives: To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component) Treatment: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule: Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
Primary Outcome
Overall Response Rate
Interventions
- DRUG Bortezomib, CHOP, Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2004-01 |
| Est. Completion | 2013-04-24 |
| Phase | Phase 1 |
What the finished NCT00151320 record still lists
NCT00151320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 1 intervention - of which Bortezomib, CHOP, Rituximab is the first listed.
NCT00151320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00151320 about?
NCT00151320 is a clinical study titled "Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL". Primary Objective: To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL) Secondary Objectives: To assess the respon...
What is the current status of trial NCT00151320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2004-01. Estimated completion is 2013-04-24.
What interventions are being tested in trial NCT00151320?
The interventions under investigation include: Bortezomib, CHOP, Rituximab (DRUG).
Who is sponsoring clinical trial NCT00151320?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00151320's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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