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No longer availableNCT04757259Updated Mar 19, 2024

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

An expanded access record providing cerdulatinib in Relapsed/Refractory Chronic Lymphocytic Leukemia and Non-hodgkin's Lymphoma, sponsored by Alexion Pharmaceuticals, Inc.. No longer available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Alexion Pharmaceuticals, Inc. · Expanded access

Study type
Expanded access
Access type
Treatment IND/protocol
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed/Refractory Chronic Lymphocytic Leukemia
  • Non-hodgkin's Lymphoma
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Access details

Study type
Expanded access
Access type
Treatment IND/protocol

Available treatment

  • Drugcerdulatinib

    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 \[BID\]).

    Also known as: PRT062070

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT04757259
Lead sponsor
Alexion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 17, 2021
Last update
Mar 19, 2024
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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