Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04844528

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

Led by University of Utah · Updated on 2025-12-03

86

Participants Needed

1

Research Sites

335 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

H

Huntsman Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Confirmed diagnosis of CLL or small lymphocytic leukemia (SLL) according to iwCLL 2018 criteria
  • History of at least one non-melanoma skin cancer diagnosed within the last 5 years
  • Adequate liver function with total bilirubin less than or equal to 1.5 times institutional upper limit of normal (ULN); for Gilbert's Syndrome, direct bilirubin less than or equal to 1.5 times ULN
  • AST(SGOT) and ALT(SGPT) less than or equal to 3 times institutional ULN
  • For females: negative pregnancy test or post-menopausal status defined by 12 months amenorrhea without other medical cause
  • Women under 50 years must be amenorrheic for at least 12 months after stopping hormonal treatments, have post-menopausal hormone levels, or have had surgical sterilization
  • Women 50 years or older must be amenorrheic for 12 months or more, have radiation- or chemotherapy-induced menopause over 1 year ago, or have had surgical sterilization
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception
Not Eligible

You will not qualify if you...

  • Received cytotoxic chemotherapy within the last 6 months
  • Received allogeneic stem cell transplant within the last 6 months
  • Taking nicotinamide or niacin supplements within the last 4 weeks
  • Taken acitretin or other oral retinoids within the past 6 months
  • Received field treatment for actinic keratoses (AKs) such as topical 5-fluorouracil, imiquimod, diclofenac, retinoids, photodynamic therapy, laser resurfacing or chemical peels within the last 4 weeks
  • Large areas of confluent skin cancer at baseline preventing accurate assessment
  • Need for ongoing carbamazepine use
  • Severe gastrointestinal malabsorption that may interfere with nicotinamide absorption
  • Expected life expectancy less than 2 years
  • Uncontrolled diabetes
  • Current or history of peptic ulcer disease
  • Known HIV infection with detectable viral load within 6 months before treatment (exceptions for undetectable viral load on effective therapy)
  • Known active uncontrolled infection
  • Medical, psychiatric, cognitive or other conditions compromising consent or study compliance
  • Prior severe hypersensitivity to the investigational product or its components
  • Taking prohibited medications without appropriate washout
  • History of solid organ transplant with ongoing immunosuppressive therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

L

Lindsey Gilstrap

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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