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Vitamin
Nicotinamide for Chronic Lymphocytic Leukemia and Skin Cancer
Phase 2
Recruiting
Led By Lindsey Fitzgerald, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of CLL or small lymphocytic leukemia (SLL) per iwCLL 2018 criteria
Adequate liver function as defined as: Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
Must not have
Need for ongoing carbamazepine use (possible interaction with nicotinamide)
Current evidence or history of peptic ulcer disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Summary
This trial is a study to see if a drug can prevent a type of skin cancer in people with a certain type of blood cancer.
Who is the study for?
This trial is for adults over 18 with Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia who've had non-melanoma skin cancer in the last 5 years. They must have normal liver function, agree to use contraception if of childbearing potential, and not be on certain medications or treatments that could interfere with the study.
What is being tested?
The trial tests whether Nicotinamide (a form of vitamin B3) taken orally can prevent new non-melanoma skin cancers in CLL patients. Participants are randomly given either Nicotinamide or a placebo for one year, then all receive Nicotinamide for another year while their skin health is monitored.
What are the potential side effects?
Potential side effects from taking Nicotinamide may include digestive upset like nausea or vomiting, flushing of the skin due to dilation of blood vessels, dizziness and itching. However, individual reactions can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL or SLL according to the latest criteria.
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My liver is functioning well, with normal bilirubin levels.
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I am 18 years old or older.
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I am not pregnant or I am post-menopausal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need to keep taking carbamazepine.
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I have or had a peptic ulcer.
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I have an ongoing infection that isn't under control.
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I have not had skin treatments for AKs in the last 4 weeks.
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My skin cancer covers large areas, making it hard to count new cancers.
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My diabetes is not under control.
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I have had chemotherapy with specific drugs in the last 6 months.
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I had a stem cell transplant from a donor within the last 6 months.
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I have had an organ transplant and am on immunosuppressive drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Chronic Lymphocytic Leukemia
Secondary study objectives
Number of new NMSC on skin exam after 1 year of treatment
frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0 and iwCLL), seriousness, duration, and relationship to study treatment
number of new NMSC developed during year 1 and year 2 for patients who receive placebo during the first year
+5 moreSide effects data
From 2022 Phase 2 trial • 46 Patients • NCT0306147425%
Diarrhoea
17%
Urinary tract infection
17%
Fall
8%
Constipation
8%
Vomiting
8%
Anxiety
8%
Laboratory test abnormal
8%
Back pain
4%
Upper respiratory tract infection
4%
Cognitive disorder
4%
Coccydynia
4%
Agitation
4%
Fungal infection
4%
Dysgeusia
4%
Syncoper
4%
Vitamin D deficiency
4%
Glomerular Ffiltration rate decreased
4%
Hypokalaemia
4%
Basal cell carcinoma
4%
Pneumonia
4%
Tremor
4%
Blood testosterone decreased
4%
Weight decreased
4%
Foot deformity
4%
Osteoporosis
4%
Headache
4%
Eructation
4%
Pleocytosis
4%
Limb injury
4%
Renal cyst
4%
Laceration
4%
Myalgia
4%
Hyperlipidaemia
4%
Dizziness
4%
Diabetes mellitus
4%
Arthralgia
4%
Thrombocytopenia
4%
Dyspepsia
4%
Infection
4%
Post lumbar puncture syndrome
4%
Neuropathy peripheral
4%
Colorectal cancer
4%
Tooth abscess
4%
Colitis ulcerative
4%
Hiatus hernia
4%
Dehydration
4%
Parkinson's disease
4%
Transaminases increased
4%
Viral upper respiratory tract infection
4%
Foot fracture
4%
Head Injury
4%
Actinic keratosis
4%
Miliaria
4%
Penile ulceration
4%
Psoriasis
4%
Rash
4%
Urticaria
4%
Cancer surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotinamide
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment: all patientsExperimental Treatment1 Intervention
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.
Group II: Arm 2: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide
2021
Completed Phase 3
~2810
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,700 Total Patients Enrolled
Lindsey Fitzgerald, MDPrincipal InvestigatorHuntsman Cancer Institute
Deborah Stephens, DOPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken acitretin or other oral retinoids in the last 6 months.You are not expected to live for more than 2 years.I need to keep taking carbamazepine.I have had at least one non-melanoma skin cancer in the past 5 years.I have or had a peptic ulcer.I have an ongoing infection that isn't under control.I have severe digestive issues that affect how my body absorbs medication.I have not had skin treatments for AKs in the last 4 weeks.I am not pregnant or I am post-menopausal.My skin cancer covers large areas, making it hard to count new cancers.My diabetes is not under control.I have been diagnosed with CLL or SLL according to the latest criteria.My liver is functioning well, with normal bilirubin levels.I have stopped taking certain medications as required before starting treatment.I have had chemotherapy with specific drugs in the last 6 months.I have taken nicotinamide or niacin supplements in the last 4 weeks.You have had a severe allergic reaction to the study drug or any of its parts in the past.I agree to use effective birth control during the study.I had a stem cell transplant from a donor within the last 6 months.You have a liver condition called Gilbert's Syndrome with specific levels of bilirubin in your blood.I have had an organ transplant and am on immunosuppressive drugs.I am 18 years old or older.I have HIV with a detectable viral load in the last 6 months.Your liver enzymes (AST and ALT) should be less than 3 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Placebo
- Group 2: Treatment: all patients
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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