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NCT04844528 · ClinicalTrials.gov registry record · Phase 2
Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers
A Phase 2 study of Chronic Lymphocytic Leukemia and Non-melanoma Skin Cancer (NMSC), sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 1
- Study location
NCT04844528: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia and Non-melanoma Skin Cancer (NMSC), sponsored by University of Utah.
NCT04844528 is a Phase 2 study of Chronic Lymphocytic Leukemia and Non-melanoma Skin Cancer (NMSC) that is actively recruiting participants, run by University of Utah. The registered enrollment target is 86 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04844528, a Phase 2 study of Chronic Lymphocytic Leukemia and Non-melanoma Skin Cancer (NMSC), is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year. Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) for 1 year or oral placebo 1 tablet twice daily for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will undergo dermatologic examination and the number of new NMSC will be quantified. The number of patients who develop new NMSC in each arm will be documented. At this time, patients will be unblinded and all patients will receive Nicotinamide 500 mg BID for an additional year. At the end of this second year, patients will again undergo dermatologic examination, and the number of new NMSC will be quantified. The number of patients who develop NMSC will be documented. Skin biopsies will be taken for correlative studies. Enrollment will be split into two parts separated by an interim analysis. Part 1 will accrue 40 patients: 20 to each arm. After 40 patients have completed their 12 month visit an interim futility analysis will be conducted prior to recruiting more patients. The study will stop if the difference in the number of patients with NMSC between control and treatment arms is 0 or less (i.e., absolutely no evidence that the treatment is better than control). If the trial is not stopped, the investigators will proceed with Part 2 and recruit 46 more patients.
Primary Outcome
evaluate whether nicotinamide can reduce the number of patients who develop one or more new NMSC versus placebo in CLL patients with a history of NMSC.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nicotinamide
Study Locations (1)
Utah
- Huntsman Cancer Institute at University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-02-25 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT04844528 shows while recruiting
NCT04844528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (52% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04844528 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04844528 about?
NCT04844528 is a clinical study titled "Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers". This is a randomized, phase II, double-blind, placebo-controlled trial with planned crossover to the intervention arm after 1 year. Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive either oral nicotinamide 500 mg twice daily (BID) ...
What is the current status of trial NCT04844528?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2022-02-25. Estimated completion is 2028-08.
What conditions does trial NCT04844528 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-melanoma Skin Cancer (NMSC).
What interventions are being tested in trial NCT04844528?
The interventions under investigation include: Placebo (DRUG), Nicotinamide (DRUG).
Who is sponsoring clinical trial NCT04844528?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04844528 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04844528's enrollment target sits among peer trials
86 71st of 187 higher than 117 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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