Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06630091

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

Led by M.D. Anderson Cancer Center · Updated on 2026-02-17

30

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before study procedures
  • Submission of tumor tissue sample for central confirmation
  • Age 18 years or older
  • ECOG performance status of 0 to 2 without recent decline
  • Life expectancy of at least 12 weeks
  • Histologically confirmed peripheral T-cell lymphoma of specified subtypes
  • Measurable disease according to 2014 Lugano classification with specified size criteria
  • No prior systemic treatment for T-cell lymphoma
  • Adequate bone marrow and organ function as defined by lab values
  • Left ventricular ejection fraction (LVEF) of 50% or higher
  • Ability and willingness to comply with study requirements
  • Agreement to use adequate contraception during and after study participation
Not Eligible

You will not qualify if you...

  • Previous treatment with investigational anti-cancer agents or chemotherapy
  • Use of corticosteroids higher than prednisone 40 mg/day within 7 days before study
  • Recent major surgery or traumatic injury within 4 weeks before study treatment
  • Prior treatment with JAK or STAT3 inhibitors
  • Prior onco-immunotherapy within 28 days before dosing
  • Recent live vaccines within 28 days before dosing
  • Use of medications or supplements that strongly affect CYP3A that cannot be stopped
  • Central nervous system or leptomeningeal lymphoma
  • Severely reduced lung function or active interstitial lung diseases
  • Conditions requiring immunosuppressants, biologics, or NSAIDs
  • Active infections including tuberculosis, HIV, active hepatitis B or C, or others needing antimicrobial therapy
  • Significant cardiac conditions including heart failure, arrhythmias, recent myocardial infarction, or heart transplant
  • Other malignancies within 5 years except certain treated skin or cervical cancers
  • Severe nausea, vomiting, gastrointestinal diseases, or inability to absorb the study drug
  • Known hypersensitivity to golidocitinib or related drugs
  • Severe or uncontrolled systemic diseases, uncontrolled hypertension, or active bleeding
  • Conditions or situations that may prevent compliance with the study
  • Psychiatric or social conditions limiting study adherence
  • Pregnant or breastfeeding women
  • Need to avoid medications or foods affecting CYP3A activity during study and washout period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

L

Luis Malpica Castillo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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