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NCT00554827 · ClinicalTrials.gov registry record · Phase 1
Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
A Phase 1 study of Cutaneous T Cell Lymphoma, sponsored by Acrotech Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 10
- Study locations
NCT00554827: Completed Phase 1 study of Cutaneous T Cell Lymphoma, sponsored by Acrotech Biopharma.
NCT00554827 is a Phase 1 study of Cutaneous T Cell Lymphoma that has completed, run by Acrotech Biopharma. The registered enrollment target is 55 participants, below the 65-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (15% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00554827, a Phase 1 study of Cutaneous T Cell Lymphoma, has completed, sponsored by Acrotech Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
Response rate was used as the primary measure of efficacy during the process of identifying a well-tolerated and effective dosing regimen of pralatrexate in patients with relapsed/refractory CTCL. Duration of response was defined as the number of days between the date of first tumor response assessment of objective response (CR, CRu, or PR, whichever was recorded first) and the first date that recurrent disease or PD was objectively documented or death.
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
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT00554827 record still lists
NCT00554827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 65-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (15% lower).
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.
NCT00554827 lists 10 locations in 8 states (California, New York, Connecticut).
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.
What interventions are being tested in trial NCT00554827?
The interventions under investigation include: Vitamin B12 (DIETARY_SUPPLEMENT), Pralatrexate (DRUG), Folic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00554827?
This trial is sponsored by Acrotech Biopharma, which has 24 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00554827's enrollment target sits among peer trials
55 9th of 23 higher than 15 of 23 other Cutaneous T Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cutaneous T Cell Lymphoma 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.
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