Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2026
  • participants needed
    86
  • sponsor
    University of Utah
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Updated on 26 March 2022
See if I qualify
cancer
chronic lymphocytic leukemia
gilbert's syndrome

Summary

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.

Details
Condition Chronic Lymphocytic Leukemia
Treatment Placebo, Nicotinamide
Clinical Study IdentifierNCT04844528
SponsorUniversity of Utah
Last Modified on26 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female subject aged ≥ 18 years
Histologically confirmed diagnosis of CLL per iwCLL 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 ≤
5x ULN
AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
For female subjects: Negative pregnancy test or evidence of post-menopausal status
\--Women < 50 years of age
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
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
Underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
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
Women ≥ 50 years of age
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 as described in Section 5.4.1

Exclusion Criteria

Received chemotherapy (such as 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
Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination, radiographic findings, and TB testing in line with local
practice), or hepatitis C
Note: Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase
chain reaction is negative for HCV RNA
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 Section 6.7.1. 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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