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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 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 76 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00151320
The ClinicalTrials.gov registry entry for NCT00151320 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bortezomib, CHOP, Rituximab is the first listed.
NCT00151320 reports 0 study locations.
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.
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