Status:
RECRUITING
Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Huntsman Cancer Institute
Conditions:
Chronic Lymphocytic Leukemia
Non-melanoma Skin Cancer (NMSC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 diagnos...
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.
- 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.
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04844528
Start Date
February 25 2022
End Date
August 1 2028
Last Update
December 3 2025
Active Locations (1)
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1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112