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NCT00504751 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00504751 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants.
The verdict
NCT00504751, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Objectives The primary objective of this study is to: • determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma The secondary objectives of this study are to: * assess event free survival and overall survival * assess conversion of chemo-resistant to chemo-sensitive disease * assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation * perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity
Interventions
- DRUG bortezomib, dexamethasone, ifosfamide
- DRUG mesna, cisplatin, etoposide, rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-02-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00504751
The ClinicalTrials.gov registry entry for NCT00504751 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 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 2 interventions - of which bortezomib, dexamethasone, ifosfamide is the first listed.
NCT00504751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00504751 about?
NCT00504751 is a clinical study titled "Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL". Objectives The primary objective of this study is to: • determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory di...
What is the current status of trial NCT00504751?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2007-05. Estimated completion is 2012-02-17.
What interventions are being tested in trial NCT00504751?
The interventions under investigation include: bortezomib, dexamethasone, ifosfamide (DRUG), mesna, cisplatin, etoposide, rituximab (DRUG).
Who is sponsoring clinical trial NCT00504751?
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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