- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757259
Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
March 18, 2024 updated by: Alexion Pharmaceuticals, Inc.
An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
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.
Study Overview
Status
No longer available
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexion Pharmaceuticals, Inc.
- Phone Number: 855-752-2356
- Email: 20-605.eap@alexion.com
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
First Submitted
February 10, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (Actual)
February 17, 2021
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Chronic Disease
- Leukemia, Lymphocytic, Chronic, B-Cell
Other Study ID Numbers
- 20-605
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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