About this trial
To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of a signed and dated, written informed consent form prior to any study specific procedures, sampling, and analyses.
Submission of the tumor block or unstained slides from an excisional or core biopsy from nodal or extra-nodal lymphoma tissue (archived or newly obtained sample) is required for retrospective central confirmation of tumor histological subtype.
Aged ≥ 18 years old.
Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks.
Disqualifiers
Any investigational anti-cancer agents or anti-cancer study drugs from a previous clinical study.
Any cytotoxic chemotherapy from a previous treatment regimen.
Corticosteroids at dosages equivalent to prednisone > 40 mg/day within 7 days of the start of the study treatment.
Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
Trial design
Single group
Treatments tested in this trial
Golidocitinib
Drug150 mg once per day by PO
Cyclophosphamide
Drug750 mg/m2 by IV
Doxorubicin
Drug50 mg/m2 by IV
Vincristine
Drug1.4 mg/m2 (max: 2 mg) by IV
Prednisone
Drug100 mg by PO
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Sponsors and contacts
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