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Go-CHOP as the Frontline Therapy for PTCL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Go-CHOP as the Frontline Therapy for PTCL

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)

NCT05963347•Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must sign an informed consent form prior to trial-specific procedures, sampling, and analysis.
•2. Participants must be at least 18 years of age (inclusive) at the time of signing the informed consent form.
•3. The participant has an ECOG performance status of 0 to 2 and has not deteriorated in the past 2 weeks.
•4. Life expectancy ≥ 3 months.
•5. Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphoma therapy; and assessed by a local pathologist according to the 2016 revised World Health Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) as the following subtypes:
•* peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)
•* angioimmunoblastic T cell lymphoma (AITL)
•* follicular T-cell lymphoma (FTCL)
•* nodular PTCL with follicular helper T-cell phenotype (nodular PTCL with TFH phenotype)
•* ALK- anaplastic large cell lymphoma (ALK- ALCL)
+9 more criteria

Exclusion Criteria

•1. Received any of the following interventions:
•* Prior therapy for PTCL prior to enrollment, except short-term corticosteroids (duration ≤ 7 days, equivalent prednisone dose ≤ 15 mg/day).
•* Prior radiation therapy for PTCL except local therapy for individual areas.
•* Currently receiving other systemic antineoplastic or investigational therapy.
•* Participants who have received more than 200 mg/m2 doxorubicin or other equivalent doses of anthracycline/anthraquinone (e.g., epirubicin, daunorubicin, mitoxantrone, etc.) cumulatively.
•* Major surgical procedures (excluding routine lymphoma care programs such as vascular access placement, biopsy, etc.) or significant trauma within 4 weeks prior to the first dose of study treatment, or anticipation of the need for major surgery during the study.
•* Prior treatment with JAK or STAT3 inhibitors following diagnosis of PTCL.
•* Live vaccine within 28 days prior to enrollment.
•* Participants currently receiving (or unable to discontinue for at least 1 week prior to first dose) vitamin K antagonists, antiplatelets, or anticoagulants.
•* Participants currently receiving (or unable to discontinue for at least 1 week prior to receiving the first dose) medications or herbal supplements known to be highly potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or P-gp with a narrow therapeutic index (see Section 6.8).
+13 more criteria

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Key Dates

Start Date

August 3, 2023

Primary Completion Date

July 30, 2025

Completion Date

July 31, 2026

Last Updated

September 1, 2023

Enrollment

ESTIMATED participants

Conditions

Peripheral T Cell Lymphoma

Interventions

Golidocitinib

DRUG

CHOP Regimen

DRUG

Contacts

Keshu Zhou, Dr.

CONTACT

+86 (0371) 65587513 drzhouks77@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Go-CHOP as the Frontline Therapy for PTCL

Inclusion Criteria

Exclusion Criteria

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