Effects of Nicotinamide on Chronic Lymphocytic Leukemia Patients with Skin Cancer History

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the effects of oral nicotinamide on patients diagnosed with chronic lymphocytic leukemia (CLL) who have a history of non-melanoma skin cancers (NMSC). Participants will be randomly assigned to receive either nicotinamide or a placebo for one year, followed by a crossover to nicotinamide for all participants in the second year. The study aims to quantify the number of new NMSC cases developed in each group after one and two years, with dermatologic examinations and skin biopsies conducted for further analysis. The trial is designed to assess the potential protective effects of nicotinamide against the development of new skin cancers in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Lindsey Fitzgerald, MD — Huntsman Cancer Institute
• Study coordinator: Lindsey Gilstrap
• Email: lindsey.gilstrap@hci.utah.edu
• Phone: 801-213-4233

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.