Status and phase
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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.
Enrollment
Sex
Ages
Volunteers
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:
Women ≥ 50 years of age:
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
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.
Primary purpose
Allocation
Interventional model
Masking
86 participants in 2 patient groups, including a placebo group
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Central trial contact
Catherine Cromar; Lindsey Gilstrap
Data sourced from clinicaltrials.gov
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