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NCT04844528

Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from University of Utah

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Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Aug 2027
    • Eligibility criteria expanded, about 42 words
    • Publications: details revised at 13 of 17 entries
  2. Site contact updated
    • Study title shortened, about 2 words
    v11
  3. Primary completion date: Aug 1, 2025 to Aug 2026v10 Show 4 more changesShow less
    • Start date: Aug 5, 2021 to Feb 25, 2022
    • Eligibility criteria shortened, about 5 words
    • Study completion date: Aug 1, 2027 to Aug 2028
    • Collaborators expanded, about 3 words
  4. Primary completion date: Aug 1, 2024 to Aug 1, 2025
    • Study completion date: Aug 1, 2026 to Aug 1, 2027
    v9
  5. Site contact updatedv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria shortened, about 37 wordsv7
  2. Primary completion date: Aug 1, 2023 to Aug 1, 2024v6
  3. Trial status: Suspended to Recruiting
    • Secondary endpoints revised (8)
    • Site details revised
    v5
  4. Trial status: Recruiting to Suspended Sponsor's reason: pending change in drug supplier
    • Site details revised
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2021 to Aug 5, 2021
    v3
  6. Eligibility criteria revised
    • Secondary endpoints revised (8)
    • Study title shortened, about 4 words
    v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Proportion of CLL patients who develop a new NMSC after 1 year of nicotinamide therapy.
Timeframe: 1 year

Secondary (8)

Number of new NMSC on skin exam after 1 year of treatment
proportion of CLL patients who develop squamous cell carcinoma (SCC) on skin exam after 1 and 2 years of treatment.
proportion of CLL patients who develop basal cell carcinoma (BCC) on skin exam after 1 and 2 years of treatment.
proportion of CLL patients who develop actinic keratosis (AK) on skin exam after 1 and 2 years of treatment.
number of new NMSC developed during year 1 and year 2 for patients who receive placebo during the first year
Show 3 moreShow less
objective response rate (the proportion of subjects achieving a complete response [CR] or partial response [PR]) and complete response rate as calculated per International Workshop on CLL (IWCLL) 2018 Criteria at Month 6, 12, 18, and 24
objective response rate (the proportion of subjects achieving a CR or PR) and complete response rate as calculated per International Workshop on CLL (IWCLL) 2018 Criteria at Month 6, 12, 18, and 24
frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0 and iwCLL), seriousness, duration, and relationship to study treatment

Arms and interventions

Nicotinamide, Then NicotinamideExperimental

Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive oral nicotinamide 500 mg twice daily (BID) 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 be unblinded, and all patients will receive Nicotinamide 500 mg BID for an additional year.

Placebo, Then NicotinamideExperimental

Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive placebo twice daily (BID) 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 be unblinded, and all patients will receive Nicotinamide 500 mg BID for an additional year.

Drugs: Nicotinamide, Placebo

Sites

1 site in 1 country

  • Huntsman Cancer Institute at University of UtahSalt Lake City, Utah, United States