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NCT00764517 · ClinicalTrials.gov registry record · Phase 2

Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma

A Phase 2 study, sponsored by OHSU Knight Cancer Institute.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target

NCT00764517: Completed Phase 2 study, sponsored by OHSU Knight Cancer Institute.

NCT00764517 is a Phase 2 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00764517, a Phase 2 study, has completed, sponsored by OHSU Knight Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target

Study Summary

This phase II trial studies how well giving vorinostat, cladribine, and rituximab together works in treating patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or B cell non-Hodgkin's lymphoma (NHL) that has returned after a period of improvement. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving vorinostat together with cladribine and rituximab may kill more cancer cells.

Primary Outcome

ORR defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR). Assessed per the revised Cheson criteria. Response definitions per revised International Working Group Response Criteria. 95% confidence interval will be provided. Definitions: Complete response (CR) = disappearance of all evidence of disease; Partial response (PR) = regression of measurable disease and no new sites.

Interventions

  • DRUG Cladribine
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Rituximab
  • DRUG Vorinostat

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2008-08
Est. Completion 2017-03
Phase Phase 2
OHSU Knight Cancer Institute

211 total trials

What the finished NCT00764517 record still lists

NCT00764517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 4 interventions - of which Cladribine is the first listed.

NCT00764517 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00764517 about?

NCT00764517 is a clinical study titled "Vorinostat, Cladribine, and Rituximab in Treating Patients With Mantle Cell Lymphoma, Relapsed Chronic Lymphocytic Leukemia, or Relapsed B Cell Non-Hodgkin's Lymphoma". This phase II trial studies how well giving vorinostat, cladribine, and rituximab together works in treating patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or B cell non-Hodgkin's lymphoma (NHL) that has returned after a period of improvement. Vorinostat may stop the g...

What is the current status of trial NCT00764517?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2008-08. Estimated completion is 2017-03.

What interventions are being tested in trial NCT00764517?

The interventions under investigation include: Cladribine (DRUG), Laboratory Biomarker Analysis (OTHER), Rituximab (BIOLOGICAL), Vorinostat (DRUG).

Who is sponsoring clinical trial NCT00764517?

This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00764517's enrollment target sits among peer trials

57 1141st of 2000 higher than 855 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 NCT00764517, the US trial registry maintained by the National Library of Medicine. NCT00764517 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.