Back to resultsExpanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
Primary Purpose
Relapsed/Refractory Chronic Lymphocytic Leukemia, Non-hodgkin's Lymphoma
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
cerdulatinib
Sponsored by
About this trial
This is an expanded access trial for Relapsed/Refractory Chronic Lymphocytic Leukemia
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04757259
Brief Title
Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
Official Title
An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
Study Type
Expanded Access
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Chronic Lymphocytic Leukemia, Non-hodgkin's Lymphoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cerdulatinib
Other Intervention Name(s)
PRT062070
Intervention Description
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]).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexion Pharmaceuticals, Inc.
Phone
855-752-2356
Email
20-605.eap@alexion.com
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
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