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New treatment option for Chronic Lymphocytic Leukemia
Official title Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia With History of Non-melanoma Skin Cancers
ClinicalTrials.gov ID: NCT04844528
What this study is testing
What is Nicotinamide?
Nicotinamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as Niacinamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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) ---people with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN
You likely can't join if
- 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...
- Large areas of confluent skin cancer at baseline preventing accurate assessment and counting of individual new skin cancers
See the full eligibility 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) ---people with a known diagnosis of Gilbert's Syndrome: direct bilirubin ≤ 1.5x ULN
- AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- For female people: 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...
- 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 people of childbearing potential and male people with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
- 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: people on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated...
- 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).
- people 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...
- Have ever received a solid organ transplant and are currently taking immunosuppressive medications.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.