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COMPLETED Phase 1

Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

NCT00554827 · View on ClinicalTrials.gov ↗

Study Summary

This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previous treatment). It is also being conducted to get information on whether or not pralatrexate is effective in treating relapsed or refractory CTCL.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Vitamin B12
  • DRUG Pralatrexate
  • DIETARY_SUPPLEMENT Folic Acid

Study Locations (10)

California

  • City of Hope National Medical Center — Duarte
  • Stanford University School of Medicine — Redwood City

New York

  • Memorial Sloan-Kettering Cancer Center — New York
  • Columbia University Medical Center — New York

Connecticut

  • Yale University School of Medicine — New Haven

Georgia

  • Emory University — Atlanta

Massachusetts

  • Dana-Farber Cancer Institute — Boston

Missouri

  • Washington University School of Medicine — St Louis

Texas

  • University of Texas MD Anderson Cancer Center — Houston

Washington

  • Fred Hutchinson Cancer Center — Seattle

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2007-08
Est. Completion 2012-02
Phase Phase 1

Sponsor

Acrotech Biopharma

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00554827

The ClinicalTrials.gov registry entry for NCT00554827 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acrotech Biopharma, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cutaneous T-cell Lymphoma appearing as the primary indexed condition, and to 3 interventions — of which Vitamin B12 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00554827 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, New York, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00554827 about?

NCT00554827 is a clinical study titled "Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma". This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previ...

What is the current status of trial NCT00554827?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2007-08. Estimated completion is 2012-02.

What conditions does trial NCT00554827 study?

This clinical trial studies the following conditions: Cutaneous T-cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00554827?

The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate (DRUG), Folic Acid (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00554827?

This trial is sponsored by Acrotech Biopharma, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00554827 being conducted?

This trial has 10 study locations across California, Connecticut, Georgia, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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