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NCT01676831 · ClinicalTrials.gov registry record · Phase 1
Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)
A Phase 1 study of Cutaneous T Cell Lymphoma, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01676831: Completed Phase 1 study of Cutaneous T Cell Lymphoma, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01676831 is a Phase 1 study of Cutaneous T Cell Lymphoma that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 13 participants, below the 67-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01676831, a Phase 1 study of Cutaneous T Cell Lymphoma, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to explore the safety and the preliminary efficacy of two concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA) Cutaneous T Cell Lymphoma patients. This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Products Development, FDA.
Primary Outcome
After four subjects have completed at least four weeks of study drug dosing a safety review meeting will be conducted by a safety review committee. No subjects will be enrolled in the next concentration (0.03%)group until all eight have been evaluated in the 0.06% group. The safety review committee reviews all patient data including adverse events to indicate whether the patient can escalate to the highest dose.
Conditions Studied
Interventions
- DRUG Topical resiquimod 0.06%
- DRUG topical resiquimod 0.03%
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2012-02 |
| Est. Completion | 2015-09-28 |
| Phase | Phase 1 |
What the finished NCT01676831 record still lists
NCT01676831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 67-participant average among 23 other Cutaneous T Cell Lymphoma trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Cutaneous T Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Topical resiquimod 0.06% is the first listed.
NCT01676831 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01676831 about?
NCT01676831 is a clinical study titled "Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)". The objective of this study is to explore the safety and the preliminary efficacy of two concentrations (0.06% and 0.03%)gel that is applied to lesions of early stage (IA, IB,IIA) Cutaneous T Cell Lymphoma patients. This study is supported by grant 1R01FD004092-01A1 from the Office of Orphan Produc...
What is the current status of trial NCT01676831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2012-02. Estimated completion is 2015-09-28.
What conditions does trial NCT01676831 study?
This clinical trial studies the following conditions: Cutaneous T Cell Lymphoma.
What interventions are being tested in trial NCT01676831?
The interventions under investigation include: Topical resiquimod 0.06% (DRUG), topical resiquimod 0.03% (DRUG).
Who is sponsoring clinical trial NCT01676831?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01676831 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01676831's enrollment target sits among peer trials
13 22nd of 23 higher than 2 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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