Status:
UNKNOWN
Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA
Lead Sponsor:
Andria Ford
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
In this prospective, single-arm, open-label, imaging and treatment study, the investigator will test the hypothesis that crizanlizumab will prevent the progression of silent cerebral infarcts in patie...
Eligibility Criteria
Inclusion
- Adult participants age 16 and older
- Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype
- Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria:
- Silent cerebral infarcts visualized on FLAIR MRI within previous two years
- Intracranial or extracranial cervical artery vasculopathy
- History of overt ischemic or hemorrhagic stroke and Intolerance and/or failure of other therapies to prevent cerebral infarction
- Increased severity of sickle cell disease including having between 2 and 10 sickle cell-related pain crises within the preceding 12 months as determined by medical history or by patient's recall (crises should include the occurrence of appropriate symptoms, a visit to a specific medical facility and/or health care professional, and receipt of pain medication).
- Increased risk deemed by other objective laboratory and/or imaging results which have been associated with increased risk of cerebral infarction
- Provide written informed consent.
- Normal hematologic function defined as: WBC \> 4x10\^9 / L, ANC \>1.5x10\^9 / L and platelets \> 100x10\^9 / L
- Females of childbearing potential (FCBP) must agree to refrain from becoming pregnant while on crizanlizumb and for 3 months after discontinuation from crizanlizumab, and must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc.), barrier method contraception (i.e. condoms), or abstinence during the time-frame
Exclusion
- Current chronic transfusion therapy
- Planning for hematopoietic stem cell transplant or cerebral revascularization procedure
- Use of other investigational drug within one year of study participation
- Other medical/neurological/social/substance abuse history that would alter brain MRI findings prospectively
- Inability to return for follow-up
- Contraindication to MRI
- Acute bacterial, fungal, or viral infection
- Known HIV, untreated latent tuberculosis (TB), or active hepatitis B or C infection or zoster
- Pregnant and/or breastfeeding. Negative pregnancy test required prior to starting study treatment.
- Known hypersensitivity to one or more of the study agents
- Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug
- Liver function tests (LFT) higher than 3x the upper limit of normal
- Treatment with other monoclonal antibody medications within last 30 days
- Treatment with various forms of anticoagulation within last 30 days, including but not limited to coumadin or direct thrombin inhibitors
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05334576
Start Date
August 1 2022
End Date
July 1 2025
Last Update
March 6 2023
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110