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NCT00364923 · ClinicalTrials.gov registry record · Phase 2

Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

A Phase 2 study of Peripheral T-Cell Lymphoma, sponsored by Acrotech Biopharma.

Completed
Registry status
Phase 2
Development phase
115
Enrollment target
20
Study locations

NCT00364923 is a Phase 2 study of Peripheral T-Cell Lymphoma that has completed, run by Acrotech Biopharma. The registered enrollment target is 115 participants, above the 103-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT00364923, a Phase 2 study of Peripheral T-Cell Lymphoma, has completed, sponsored by Acrotech Biopharma.

COMPLETED
Registry status
Phase 2
Development phase
115 participants
Enrollment target
20
Study locations

Study Summary

Primary • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) Secondary * Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL * Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation

Conditions Studied

Peripheral T-Cell Lymphoma

Interventions

  • DRUG Pralatrexate Injection

Study Locations (20)

New York

  • Memorial Sloan-Kettering Cancer Center - New York
  • New York Presbyterian Hospital - New York
  • Columbia University Medical Center - New York
  • University of Rochester Cancer Center - Rochester

California

  • City of Hope National Medical Center - Duarte
  • University of California at Los Angeles - Los Angeles

Other

  • Cliniques Universitaire Saint-Luc - Brussels
  • Cliniques Universitaires UCL - Yvoir

Connecticut

  • Yale University School of Medicine - New Haven

Georgia

  • Emory University - Atlanta

Illinois

  • University of Chicago Hospital - Chicago

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Louisiana

  • Tulane Cancer Center - New Orleans

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2006-08
Est. Completion 2009-02-24
Phase Phase 2

Sponsor

Acrotech Biopharma

24 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00364923

The ClinicalTrials.gov registry entry for NCT00364923 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 103-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (12% higher). The listed sponsor is Acrotech Biopharma, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Pralatrexate Injection is the first listed.

NCT00364923 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, California, Other.

Frequently Asked Questions

What is clinical trial NCT00364923 about?

NCT00364923 is a clinical study titled "Study of Pralatrexate With Vitamin B12 and Folic Acid in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma". Primary • Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) Secondary * Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid suppl...

What is the current status of trial NCT00364923?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2006-08. Estimated completion is 2009-02-24.

What conditions does trial NCT00364923 study?

This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma.

What interventions are being tested in trial NCT00364923?

The interventions under investigation include: Pralatrexate Injection (DRUG).

Who is sponsoring clinical trial NCT00364923?

This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00364923 being conducted?

This trial has 20 study locations across California, Connecticut, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.