Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
NCT ID: NCT04757259
Last Updated: 2024-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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cerdulatinib
Participants will receive oral cerdulatinib at the starting dose he or she was receiving at completion of Study 13-601 (30, 25, 20, or 15 milligrams \[mg\] twice daily \[BID\]).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the opinion of the Investigator, the potential benefit to the participant of continuing to receive cerdulatinib outweighs the risks.
* Female participants of childbearing potential and male participants must agree to continue to abstain from sexual intercourse or to remain on an effective method of contraception during treatment and for 90 days following the last dose of protocol therapy (examples of effective methods of contraception include oral contraceptives or double barrier methods, such as condom plus spermicide or condom plus diaphragm).
* Participant must be willing to give written informed consent and be able to adhere to dose and visit schedules.
Exclusion Criteria
* Participant has a known hypersensitivity to any of the components of cerdulatinib.
* Participant is female and is breast-feeding, pregnant, or intends to become pregnant.
* Participant is participating in any therapeutic clinical study.
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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20-605
Identifier Type: -
Identifier Source: org_study_id
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