Vitamin B3 pill may shield CLL patients from skin cancer
NCT ID NCT04844528
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking nicotinamide (a form of vitamin B3) twice daily for one year can reduce the number of new non-melanoma skin cancers in people with chronic lymphocytic leukemia (CLL) who have already had at least one such skin cancer. About 86 participants will be randomly assigned to receive either nicotinamide or a placebo. After one year, everyone will take nicotinamide for another year. The goal is to see if this simple supplement can lower skin cancer risk in this vulnerable group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 86 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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. Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huntsman Cancer Institute at University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?