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NCT00515138 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
A Early Phase 1 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT00515138 is a Early Phase 1 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 7 participants.
The verdict
NCT00515138, a Early Phase 1 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7 mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6.
Interventions
- DRUG Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00515138
The ClinicalTrials.gov registry entry for NCT00515138 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib is the first listed.
NCT00515138 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00515138 about?
NCT00515138 is a clinical study titled "A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant". This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed...
What is the current status of trial NCT00515138?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2007-05. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00515138?
The interventions under investigation include: Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00515138?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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