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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: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.

NCT00504751 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Complete Response

Interventions

  • DRUG bortezomib, dexamethasone, ifosfamide
  • DRUG mesna, cisplatin, etoposide, rituximab

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2007-05
Est. Completion 2012-02-17
Phase Phase 2

What the finished NCT00504751 record still lists

NCT00504751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which bortezomib, dexamethasone, ifosfamide is the first listed.

NCT00504751 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00504751's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00504751, the US trial registry maintained by the National Library of Medicine. NCT00504751 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.