Clinical trial · Expanded Access

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

An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

NCT04757259CI-TRIAL-00075199no longer availableClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-hodgkin's Lymphoma	Non-Hodgkin Lymphoma	ALIAS	0.90
Relapsed/Refractory Chronic Lymphocytic Leukemia	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
cerdulatinib	Drug	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.