Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04757259
Expanded Access Status : Available
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Information provided by (Responsible Party):
Alexion Pharmaceuticals

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.

Condition or disease Intervention/treatment
Relapsed/Refractory Chronic Lymphocytic Leukemia Non-hodgkin's Lymphoma Drug: cerdulatinib

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
Official Title: An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

Intervention Details:
  • 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]).
    Other Name: PRT062070

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04757259

Layout table for location contacts
Contact: Alexion Pharmaceuticals, Inc. 855-752-2356

Sponsors and Collaborators
Alexion Pharmaceuticals
Layout table for additonal information
Responsible Party: Alexion Pharmaceuticals Identifier: NCT04757259    
Other Study ID Numbers: 20-605
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia, B-Cell