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 |
| 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 |