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NCT00863369 · ClinicalTrials.gov registry record · Phase 1
Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00863369: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT00863369 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00863369, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, 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 bortezomib together with gemcitabine hydrochloride and rituximab may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and gemcitabine hydrochloride when given together with rituximab and to see how well they work in treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma.
Primary Outcome
Adverse events were graded by NCI CTCAE, Version 3.0. DLT defined as grade 4 thrombocytopenia, or grade 3 thrombocytopenia lasting greater than 7 days. Grade 4 neutropenia lasting 7 days or more despite use of growth factors. Febrile neutropenia only is it occurs after 7 days of neutropenia. Any grade 3 or higher non-hematologic toxicity related to the study drug, with the exception of alopecia, inadequately treated nausea, vomiting and/or diarrhea and fatigue.
Interventions
- OTHER questionnaire administration
- BIOLOGICAL rituximab
- DRUG bortezomib
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2005-06-29 |
| Est. Completion | 2023-06-20 |
| Phase | Phase 1 |
What the finished NCT00863369 record still lists
NCT00863369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which questionnaire administration is the first listed.
NCT00863369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00863369 about?
NCT00863369 is a clinical study titled "Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma". RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. M...
What is the current status of trial NCT00863369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2005-06-29. Estimated completion is 2023-06-20.
What interventions are being tested in trial NCT00863369?
The interventions under investigation include: questionnaire administration (OTHER), rituximab (BIOLOGICAL), bortezomib (DRUG), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00863369?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00863369's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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