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

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ClinicalTrials.gov Identifier: NCT04757259
Expanded Access Status : Available
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
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

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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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT04757259


Contacts
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Contact: Alexion Pharmaceuticals, Inc. 855-752-2356 20-605.eap@alexion.com

Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov 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:
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Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell