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

ClinicalTrials.gov ID: NCT00364923

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Official title

A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT00364923
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Acrotech Biopharma Inc.; Industry
Enrollment: 115 participants

Conditions and interventions

Conditions

Peripheral T-cell Lymphoma

Interventions

Pralatrexate Injection Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2006 (Type not available)
Primary completion: Jan 2009 (Actual)
Completion: Feb 24, 2009 (Actual)
Last update posted: Dec 19, 2019

2006 – 2009

United States locations

U.S. sites: 18
U.S. states: 14
U.S. cities: 16

Facility	City	State	ZIP	Site status
City of Hope National Medical Center	Duarte	California	91010	—
University of California at Los Angeles	Los Angeles	California	90095-7077	—
Yale University School of Medicine	New Haven	Connecticut	06520	—
Emory University	Atlanta	Georgia	30322	—
University of Chicago Hospital	Chicago	Illinois	60637	—
University of Iowa Hospitals and Clinics	Iowa City	Iowa	52242	—
Tulane Cancer Center	New Orleans	Louisiana	70112	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02115	—
Washington University School of Medicine	St Louis	Missouri	63110	—
Nevada Cancer Institute	Las Vegas	Nevada	89135	—
The Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	07601	—
Memorial Sloan-Kettering Cancer Center	New York	New York	10021	—
New York Presbyterian Hospital	New York	New York	10021	—
Columbia University Medical Center	New York	New York	10032	—
University of Rochester Cancer Center	Rochester	New York	14642	—
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	—
UT MD Anderson Cancer Center	Houston	Texas	77030	—
Fred Hutchinson Cancer Research Center	Seattle	Washington	98109	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00364923, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 19, 2019 · Synced Nov 13, 2026