Actively Recruiting
Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-02-24
68
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
X
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation. The investigational intervention consisted of either golidocitinib or matching placebo capsules, administered orally at a planned dose of 150 mg once every other day. Treatment continued until disease progression, initiation of new anti-lymphoma therapy, withdrawal of informed consent, death, or investigator decision to discontinue the study, whichever occurred first. The study treatment period was divided into 28-day cycles starting from the first dose. Efficacy and safety assessments were performed at specified time points within each cycle. The maximum duration of treatment was 2 years. A total of 136 patients were enrolled, with 68 patients assigned to the golidocitinib treatment group and 68 to the placebo control group. Data on demographics and medical history were collected, and assessments including vital signs, physical examination, and PET-CT were conducted.
CONDITIONS
Official Title
Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to comply with study requirements
- Age greater than 18 years at consent
- ECOG performance status of 0 to 1 with no decline in the past 2 weeks
- Histopathologically confirmed diagnosis of PTCL subtypes: PTCL-NOS (excluding primary cutaneous), ALK-negative ALCL, AITL, follicular helper T-cell lymphoma, or PTCL with TFH phenotype
- Achieved complete or partial response after first-line standard therapy (CHOP, BV-CHP, or CHOP-like regimens)
- Transplant-ineligible (age over 65) or transplant-eligible but declined transplantation within 3 months before study start
- Adequate bone marrow and organ function as defined by specific blood count and liver/kidney function parameters
- Left ventricular ejection fraction of 50% or higher
- Willingness to participate and comply with all trial procedures
You will not qualify if you...
- Clinical stage Ann Arbor I disease
- Participation in another clinical trial with investigational or antitumor drugs within 30 days prior
- Less than 21 days since stopping cytotoxic chemotherapy before study entry
- Systemic corticosteroid use over 10 mg prednisone equivalent daily within 1 week prior
- Major surgery or significant trauma within 4 weeks prior or planned during the study
- Antitumor monoclonal antibody therapy within 4 weeks; radiotherapy within 3 weeks; toxin/radioisotope-immunoconjugate therapy within 10 weeks prior
- Prior treatment with JAK or STAT3 inhibitors
- Antitumor immunotherapy within 28 days prior
- Live-attenuated or viral vector vaccines within 28 days prior
- Current use or inability to stop anticoagulants, vitamin K antagonists, or antiplatelet agents within 1 week prior
- Use of medications that strongly affect CYP3A or sensitive substrates of BCRP/P-gp
- History of other active cancers within 5 years (except certain treated localized cancers)
- Active infections including tuberculosis, HIV/AIDS, chronic active hepatitis B or C (unless viral DNA/RNA undetectable), or other viral infections
- Active infection requiring intravenous antimicrobial therapy
- Significant cardiac disease such as heart failure (NYHA class III or higher), unstable angina, recent myocardial infarction, or serious arrhythmias
- Pregnant or lactating women or unwillingness to use contraception
- Severe psychiatric disorders or inability to consent
- Refractory nausea, vomiting, or chronic gastrointestinal disease affecting drug absorption
- Significant lung function impairment (FEV1 and DLCO less than 60% predicted)
- Unresolved drug-related toxicities above Grade 1 (except alopecia)
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
X
xianmin Song, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here