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Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma

NCT07300514 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-03-31

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating golidocitinib as maintenance therapy in adult patients with peripheral T-cell lymphoma (PTCL) who achieved complete response (CR) or partial response (PR) after first-line systemic chemotherapy and are not candidates for hematopoietic stem cell transplantation (HSCT) or decline HSCT. Eligible patients with histologically confirmed PTCL subtypes (PTCL-NOS, ALK-positive anaplastic large cell lymphoma \[ALK-ALCL\], angioimmunoblastic T-cell lymphoma \[AITL\], or follicular helper T-cell phenotype PTCL \[FTCL/PTCL-TFH\]) according to the 2016 WHO classification will be randomized 1:1 to receive oral golidocitinib or matching placebo.

Study treatment is given at 150 mg every other day in 28-day cycles for up to 2 years or until disease progression, unacceptable toxicity, start of new anti-lymphoma therapy, withdrawal of consent, or study termination. At 12 months, patients who achieve complete metabolic response on PET-CT and minimal residual disease (MRD)-negative status by ctDNA may discontinue maintenance, whereas others continue treatment up to 24 months. After treatment discontinuation, patients will be followed for disease status and survival for up to approximately 13 additional cycles. The primary endpoint is progression-free survival (PFS) assessed by investigators per Lugano 2014 criteria. Key secondary endpoints include overall survival, response rates, duration of response, time to next anti-lymphoma therapy, MRD dynamics by ctDNA, and safety.

Conditions

  • Maintenance Treatment of Peripheral T-cell Lymphoma

Interventions

DEVICE

PET-CTandct- DNAdetection

The patients who achieved CMR by PET-CT and MRD-neg by ct-DNA testing were evaluated at 12 months,One patient stopped maintenance treatment, while the rest continued for one year.

DRUG

golidocitinib

golidocitinib maintenance treatment given orally as 150mg every other day

DRUG

Placebo

Placebo given orally as 150mg every other day

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Rong Tao, MD &PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2028-12-30
Completion
2029-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300514 on ClinicalTrials.gov