Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

• Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia; Non-hodgkin's Lymphoma

• Registration Number: NCT04757259
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

This expanded access program will provide continued access to cerdulatinib to eligible participants who experienced clinical benefit from cerdulatinib in Study 13-601 (NCT01994382) and who otherwise meet the eligibility criteria.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participant has completed Portola Study 13-601 and wishes to continue treatment with cerdulatinib.
• 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 requires chronic treatment with a strong CYP3A4 inhibitor or inducer.
• 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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified