RecruitingPhase 2NCT06630091

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

30 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study (called GOLDEN) is testing whether a drug called golidocitinib — which blocks a protein involved in cancer cell growth — is safe and effective as a first-line treatment for a group of aggressive blood cancers called peripheral T-cell lymphoma (PTCL). **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with specific subtypes of peripheral T-cell lymphoma (including PTCL-NOS, AITL, follicular T-cell lymphoma, or TFH phenotype) - You have not yet received any treatment for this lymphoma - You have at least one measurable tumor - Your overall health is reasonably good (ECOG 0-2) **You may NOT be eligible if...** - You have previously received chemotherapy or JAK/STAT inhibitors for this cancer - You have CNS (brain/spinal) lymphoma - You have active TB, HIV, or active hepatitis B or C - You have significant heart problems including recent heart attack or dangerous heart rhythms - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGolidocitinib

150 mg once per day by PO

DRUGCyclophosphamide

750 mg/m2 by IV

DRUGDoxorubicin

50 mg/m2 by IV

DRUGVincristine

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

DRUGPrednisone

100 mg by PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06630091


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