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NCT00499343 · ClinicalTrials.gov registry record · Phase 2

G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target

NCT00499343: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00499343 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00499343, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target

Study Summary

Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging. 2. To determine the incidence of disease progression/relapse at 12 months in the two groups.

Primary Outcome

After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.

Interventions

  • DRUG Rituximab
  • DRUG G-CSF
  • DRUG Etoposide
  • DRUG GM-CSF
  • DRUG Isophosphamide

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2004-01
Est. Completion 2008-10
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00499343 record still lists

NCT00499343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).

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

NCT00499343 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00499343 about?

NCT00499343 is a clinical study titled "G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients". Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. To determine the degre...

What is the current status of trial NCT00499343?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2004-01. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00499343?

The interventions under investigation include: Rituximab (DRUG), G-CSF (DRUG), Etoposide (DRUG), GM-CSF (DRUG), Isophosphamide (DRUG).

Who is sponsoring clinical trial NCT00499343?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00499343's enrollment target sits among peer trials

84 822nd of 2000 higher than 1,173 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 NCT00499343, the US trial registry maintained by the National Library of Medicine. NCT00499343 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.