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

Studies

Study First Submitted Date 2021-02-10
Study First Posted Date 2021-02-17
Last Update Posted Date 2022-05-10
Verification Month Year May 2022
Verification Date 2022-05-31
Last Update Posted Date 2022-05-10

Conditions

Sequence: 52005819 Sequence: 52005820
Name Relapsed/Refractory Chronic Lymphocytic Leukemia Name Non-hodgkin's Lymphoma
Downcase Name relapsed/refractory chronic lymphocytic leukemia Downcase Name non-hodgkin's lymphoma

Id Information

Sequence: 40029531
Id Source org_study_id
Id Value 20-605

Interventions

Sequence: 52318377
Intervention Type Drug
Name cerdulatinib
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]).

Browse Conditions

Sequence: 192832562 Sequence: 192832563 Sequence: 192832564 Sequence: 192832565 Sequence: 192832566 Sequence: 192832567 Sequence: 192832568 Sequence: 192832569 Sequence: 192832570 Sequence: 192832571 Sequence: 192832572 Sequence: 192832573 Sequence: 192832574
Mesh Term Leukemia, Lymphocytic, Chronic, B-Cell Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Lymphoproliferative Disorders Mesh Term Lymphatic Diseases Mesh Term Immunoproliferative Disorders Mesh Term Immune System Diseases Mesh Term Leukemia, Lymphoid Mesh Term Leukemia Mesh Term Leukemia, B-Cell Mesh Term Chronic Disease Mesh Term Disease Attributes Mesh Term Pathologic Processes
Downcase Mesh Term leukemia, lymphocytic, chronic, b-cell Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term lymphoproliferative disorders Downcase Mesh Term lymphatic diseases Downcase Mesh Term immunoproliferative disorders Downcase Mesh Term immune system diseases Downcase Mesh Term leukemia, lymphoid Downcase Mesh Term leukemia Downcase Mesh Term leukemia, b-cell Downcase Mesh Term chronic disease Downcase Mesh Term disease attributes Downcase Mesh Term pathologic processes
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48164877
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Alexion

Central Contacts

Sequence: 11971901
Contact Type primary
Name Alexion Pharmaceuticals, Inc.
Phone 855-752-2356
Email 20-605.eap@alexion.com
Role Contact

Eligibilities

Sequence: 30668431
Gender All
Minimum Age 18 Years
Maximum Age N/A
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254293295
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Intervention Other Names

Sequence: 26583840
Intervention Id 52318377
Name PRT062070

Responsible Parties

Sequence: 28781734
Responsible Party Type Sponsor