A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Golidocitinib

    Drug

    150 mg once per day by PO

  • Cyclophosphamide

    Drug

    750 mg/m2 by IV

  • Doxorubicin

    Drug

    50 mg/m2 by IV

  • Vincristine

    Drug

    1.4 mg/m2 (max: 2 mg) by IV

  • Prednisone

    Drug

    100 mg by PO

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Golidocitinib + CHOPExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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