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

Non-hodgkin's Lymphoma Clinical Trial

Official title:

An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04757259
• Other study ID #: 20-605
• Status: No longer available

Study information

• Verified date: March 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Non-hodgkin's Lymphoma
• Relapsed/Refractory Chronic Lymphocytic Leukemia

Intervention

Drug:
• 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]).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.