Actively Recruiting
Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
Led by Fudan University · Updated on 2026-03-31
136
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and willingness to follow study requirements.
- Age 18 years or older at consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without worsening within 2 weeks before screening.
- Histologically confirmed PTCL subtypes: PTCL-not otherwise specified (excluding primary cutaneous PTCL), ALK-positive anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, or T-follicular helper phenotype PTCL.
- Achieved complete or partial response after first-line chemotherapy with CHOP, BV-CHP, or similar regimens.
- Ineligible for HSCT if over 65 years old or eligible but declined if 65 years or younger.
- Completed first-line therapy within 3 months before planned first dose.
- Adequate bone marrow and organ function including specific blood counts, liver and kidney tests, and heart function.
- Ability and willingness to comply with study procedures and follow-up.
You will not qualify if you...
- Ann Arbor stage I disease at initial diagnosis.
- Use of investigational or antineoplastic drugs within 30 days before study dose.
- Chemotherapy within 21 days before first study dose.
- Systemic corticosteroids over prednisone 10 mg/day within 7 days before first dose.
- Major surgery or severe trauma within 4 weeks before study dose or planned surgery during treatment.
- Use of antineoplastic monoclonal antibodies within 4 weeks, radiotherapy within 3 weeks, or toxin/radioisotope-conjugated antibodies within 10 weeks.
- Prior treatment with any JAK or STAT3 inhibitor.
- Immunotherapy within 28 days before first study dose.
- Live attenuated or viral vector vaccines within 28 days before first dose.
- Current use of vitamin K antagonists, antiplatelet or anticoagulants that cannot be stopped at least 7 days before first dose.
- Concomitant use of strong CYP3A inducers or inhibitors or certain other drugs that cannot be stopped at least 7 days before first dose.
- Active hepatitis C infection or unsafe hepatitis B status.
- Known HIV infection.
- Uncontrolled or significant comorbidities or lab abnormalities.
- History or evidence of significant interstitial lung disease.
- Pregnant or breastfeeding women or those unwilling to use contraception during and after treatment.
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
R
Rong Tao, MD & PhD
CONTACT
C
Chuanxu Liu, MD & PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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