A phase 2 study of Cerdulatinib in treating Cutaneous T-cell Lymphomas (CTCL)

Lead Investigator: Zachary Epstein-Peterson, Memorial Sloan Kettering Cancer Center
Title of Proposal Research: A phase 2 study of Cerdulatinib in treating Cutaneous T-cell Lymphomas (CTCL)
Vivli Data Request: 8857
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

An investigational clinical trial was conducted involving patients with various forms of non-Hodgkin lymphomas with an oral medication called cerdulatinib. Non-Hodgkin lymphoma is a family of cancers that arise from a white blood cell, which is a part of the immune system; they are common, with approximately 80,000 new cases (4% of all cancer diagnoses) expected in 2023 according to current estimates. The different forms of non-Hodgkin lymphomas treated in this trial were divided into treatment arms. One arm comprised those patients with T-cell non-Hodgkin lymphomas occurring in the skin (called CTCL) and the present study seeks to understand and publish the results (both side effects and effectiveness) of cerdulatinib in this specific population. CTCL is family of rare cancers, with approximately 2,000 new cases per year, that are in dire need of new treatments, and there was promising activity observed in patients with CTCL with cerdulatinib, so we are seeking to publish and disseminate results. It is important that providers be aware of advances that have been made in treating CTCL since new treatments are urgently needed to help patients.

We will perform a comprehensive review all records for patients with CTCL treated with cerdulatinib to describe their characteristics (using descriptive statistics), the treatment effectiveness, and side effects experienced. For effectiveness, descriptive statistics will be used to describe the response rate across different measurements, and the Kaplan-Meier method will be used to describe survival outcomes as well. Side effects will be described using descriptive methods for the rate of side effects and how severe they were. This methodology will thoroughly capture all treated patients and relevant information regarding their clinical course. We expect that this will be an important publication in the field of CTCL and will spur future research for agents similar to cerdulatinib in the future.

Requested Studies:

Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
Data Contributor: AstraZeneca
Study ID: NCT01994382
Sponsor ID: N/A