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Nicotinamide for Preventing Skin Cancer in CLL Patients

This study is testing if nicotinamide, a form of vitamin B3, can help prevent new non-melanoma skin cancers (NMSC) in people with chronic lymphocytic leukemia (CLL). You could be eligible if you are 18 or older, have a confirmed diagnosis of CLL, and have had at least one NMSC in the past five years. Participants will receive either oral nicotinamide (500 mg twice daily) or a placebo (an inactive pill) for one year. After one year, all participants will receive nicotinamide for another year. The main goal is to see how many people develop new NMSC after one year of treatment.

Study design
This is a randomized, double-blind, placebo-controlled Phase II study with 86 planned participants. It includes a crossover, meaning all participants will eventually receive nicotinamide.
What's involved
You would take oral nicotinamide or a placebo twice daily for one year, followed by nicotinamide twice daily for an additional year. You will have dermatologic examinations at the end of the first year.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 year, and all patients will receive nicotinamide for an additional year after that.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04844528

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Utah
~86 participants
Updated 2025-12-03 on ClinicalTrials.gov
What's tested:NicotinamidePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of CLL patients who develop a new NMSC after 1 year of nicotinamide therapy.
Measured over 1 year

Conditions

Chronic Lymphocytic Leukemia
Non-melanoma Skin Cancer (NMSC)

Explore related trials

Chronic Lymphocytic LeukemiaLymphoid LeukemiaSkin Carcinoma

NCT04844528

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lindsey Fitzgerald, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Lindsey Gilstrap
[email protected]
801-213-4233
Email the study team

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Eligibility criteria

Inclusion

Male or female subject aged ≥ 18 years.
Confirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria.
History of ≥1 non-melanoma skin cancer (NMSC) diagnosed within the last 5 years
Adequate liver function as defined as:
Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
Subjects with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN
AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \< 50 years of age:
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
Women ≥ 50 years of age:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago; or
Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.

Exclusion

Received cytotoxic chemotherapy (including fludarabine, cyclophosphamide, bendamustine, or chlorambucil) 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 AKs (topical use of 5-fluorouracil, imiquimod, diclofenac, retinoids; topical photodynamic therapy for AKs; laser resurfacing or chemical peel treatments for AKs) within the previous 4 weeks
Large areas of confluent skin cancer at baseline preventing accurate assessment and counting of individual new skin cancers
Need for ongoing carbamazepine use (possible interaction with nicotinamide)
Severe GI malabsorption that may interfere with absorption of nicotinamide (per investigator's discretion)
Patients with an expected life expectancy \< 2 years
Current evidence of uncontrolled, diabetes.
Current evidence or history of peptic ulcer disease.
Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
Known active uncontrolled infection.
Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
Subjects taking prohibited medications as described in study protocol. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Have ever received a solid organ transplant and are currently taking immunosuppressive medications.

What this trial measures

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

    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.