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NCT01682044 · ClinicalTrials.gov registry record · Phase 2

Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma

A Phase 2 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT01682044: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.

NCT01682044 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01682044, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together with rituximab may kill more cancer cells

Primary Outcome

Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE

Interventions

  • PROCEDURE biopsy
  • BIOLOGICAL rituximab
  • OTHER immunohistochemistry staining method
  • OTHER flow cytometry
  • BIOLOGICAL pegfilgrastim

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-04-17
Est. Completion 2016-12-22
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

What the finished NCT01682044 record still lists

NCT01682044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 5 interventions - of which biopsy is the first listed.

NCT01682044 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01682044 about?

NCT01682044 is a clinical study titled "Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma". This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Colony-stimulating factors, such as pegfil...

What is the current status of trial NCT01682044?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2007-04-17. Estimated completion is 2016-12-22.

What interventions are being tested in trial NCT01682044?

The interventions under investigation include: biopsy (PROCEDURE), rituximab (BIOLOGICAL), immunohistochemistry staining method (OTHER), flow cytometry (OTHER), pegfilgrastim (BIOLOGICAL).

Who is sponsoring clinical trial NCT01682044?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01682044's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 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 NCT01682044, the US trial registry maintained by the National Library of Medicine. NCT01682044 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.