RECRUITING

Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 patients with sickle cell disease. Study participants will undergo brain MRI before initiation of crizanlizumab and at 6 and 30 months after starting crizanlizumab infusions. The crizanlizumab cohort will be compared to a matched, observational cohort of patients not receiving crizanlizumab.

Official Title

Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA Novartis Investigator Initiated Trial: CSEG101AUS12T

Quick Facts

Study Start:2022-08-01

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05334576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult participants age 16 and older 2. Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype 3. Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria: 1. Silent cerebral infarcts visualized on FLAIR MRI within previous two years 2. Intracranial or extracranial cervical artery vasculopathy 3. History of overt ischemic or hemorrhagic stroke and Intolerance and/or failure of other therapies to prevent cerebral infarction 4. 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). 5. Increased risk deemed by other objective laboratory and/or imaging results which have been associated with increased risk of cerebral infarction 4. Provide written informed consent. 5. Normal hematologic function defined as: WBC \> 4x10\^9 / L, ANC \>1.5x10\^9 / L and platelets \> 100x10\^9 / L 6. 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	1. Current chronic transfusion therapy 2. Planning for hematopoietic stem cell transplant or cerebral revascularization procedure 3. Use of other investigational drug within one year of study participation 4. Other medical/neurological/social/substance abuse history that would alter brain MRI findings prospectively 5. Inability to return for follow-up 6. Contraindication to MRI 7. Acute bacterial, fungal, or viral infection 8. Known HIV, untreated latent tuberculosis (TB), or active hepatitis B or C infection or zoster 9. Pregnant and/or breastfeeding. Negative pregnancy test required prior to starting study treatment. 10. Known hypersensitivity to one or more of the study agents 11. Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug 12. Liver function tests (LFT) higher than 3x the upper limit of normal 13. Treatment with other monoclonal antibody medications within last 30 days 14. Treatment with various forms of anticoagulation within last 30 days, including but not limited to coumadin or direct thrombin inhibitors

Inclusion Criteria

Exclusion Criteria

1. Adult participants age 16 and older
2. Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype
3. Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria:
1. Silent cerebral infarcts visualized on FLAIR MRI within previous two years
2. Intracranial or extracranial cervical artery vasculopathy
3. History of overt ischemic or hemorrhagic stroke and Intolerance and/or failure of other therapies to prevent cerebral infarction
4. 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).
5. Increased risk deemed by other objective laboratory and/or imaging results which have been associated with increased risk of cerebral infarction
4. Provide written informed consent.
5. Normal hematologic function defined as: WBC \> 4x10\^9 / L, ANC \>1.5x10\^9 / L and platelets \> 100x10\^9 / L
6. 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

1. Current chronic transfusion therapy
2. Planning for hematopoietic stem cell transplant or cerebral revascularization procedure
3. Use of other investigational drug within one year of study participation
4. Other medical/neurological/social/substance abuse history that would alter brain MRI findings prospectively
5. Inability to return for follow-up
6. Contraindication to MRI
7. Acute bacterial, fungal, or viral infection
8. Known HIV, untreated latent tuberculosis (TB), or active hepatitis B or C infection or zoster
9. Pregnant and/or breastfeeding. Negative pregnancy test required prior to starting study treatment.
10. Known hypersensitivity to one or more of the study agents
11. Currently receiving or has received any investigational drugs within the 14 days prior to the first dose of study drug
12. Liver function tests (LFT) higher than 3x the upper limit of normal
13. Treatment with other monoclonal antibody medications within last 30 days
14. Treatment with various forms of anticoagulation within last 30 days, including but not limited to coumadin or direct thrombin inhibitors

Contacts and Locations

Study Contact

Andria Ford, MD

CONTACT

314-362-7382

forda@wustl.edu

Nkemdilim N Igwe, MS

CONTACT

314-503-2161

igwe@wustl.edu

Study Locations (Sites)

Barnes-Jewish Hospital

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Andria Ford

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-08-01

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Sickle Cell Disease