Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05963347

Go-CHOP as the Frontline Therapy for PTCL

Led by Henan Cancer Hospital · Updated on 2023-09-01

45

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in Combination with CHOP as the front-line Treatment for Participants with Peripheral T-cell Lymphomas (PTCL).

CONDITIONS

Official Title

Go-CHOP as the Frontline Therapy for PTCL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must sign an informed consent form before any trial procedures.
  • Participants must be at least 18 years old at consent.
  • ECOG performance status between 0 and 2 with no decline in the past 2 weeks.
  • Life expectancy of 3 months or more.
  • Histologically confirmed diagnosis of PTCL subtypes including PTCL-NOS, AITL, FTCL, nodular PTCL with TFH phenotype, ALK- ALCL, ALK+ ALCL, EATL, MEITL, HSTCL, or SPTCL.
  • Adequate bone marrow and organ function.
  • Left ventricular ejection fraction of 50% or higher by ECHO.
  • Willingness and ability to follow study protocol.
  • Use of adequate birth control during and after treatment.
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for PTCL except short-term corticosteroids (7 days or less, prednisone 15 mg/day or less).
  • Prior radiation therapy except for localized areas.
  • Current use of other systemic antineoplastic or investigational therapies.
  • Prior cumulative dose of doxorubicin over 200 mg/m2 or equivalent anthracycline.
  • Major surgery or significant trauma within 4 weeks before first study dose or planned during study.
  • Prior treatment with JAK or STAT3 inhibitors after PTCL diagnosis.
  • Live vaccine within 28 days before enrollment.
  • Use of vitamin K antagonists, antiplatelets, or anticoagulants not discontinued at least 1 week before first dose.
  • Use of medications or supplements affecting CYP3A, BCRP, or P-gp not discontinued at least 1 week before first dose.
  • Central nervous system or leptomeningeal lymphoma.
  • Severe lung disease or history of interstitial lung disease requiring steroids.
  • Conditions requiring immunosuppressants, biologics, or NSAIDs.
  • Active infections.
  • Significant cardiac disorders.
  • Other malignancies within 3 years, except certain cured skin and cervical cancers.
  • Severe nausea, vomiting, gastrointestinal disease affecting drug absorption.
  • Lactating females.
  • Hypersensitivity to golidocitinib or CHOP agents.
  • Severe or uncontrolled systemic diseases.
  • Intercurrent illnesses that may affect protocol compliance.
  • Conditions preventing study compliance such as psychological or social issues.
  • Participation in study planning or implementation.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Henan Cancer Hospital

Zhengzhou, Henan, China, 450008

Actively Recruiting

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Research Team

K

Keshu Zhou, Dr.

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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Go-CHOP as the Frontline Therapy for PTCL | DecenTrialz