Actively Recruiting
A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL
Led by Sun Yat-sen University · Updated on 2025-03-04
33
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.
CONDITIONS
Official Title
A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand the study and give voluntary informed consent
- Participants of any gender aged 18 to 80 years
- Histopathological confirmation of peripheral T-cell lymphoma as per WHO 2016 criteria
- Relapsed or refractory disease after prior systemic therapy, including possible stem cell transplantation
- At least one measurable lesion meeting Lugano2014 criteria
- ECOG performance status score between 0 and 2
- Laboratory values meeting specified minimum counts and liver and kidney function limits
- No radiotherapy, chemotherapy, targeted therapy, or stem cell transplantation within 3 weeks prior to enrollment
- Life expectancy of at least six months as judged by investigators
You will not qualify if you...
- Hemophagocytic syndrome
- Central nervous system or meningeal lymphoma involvement
- History of malignant tumors within 5 years except certain locally curable cancers
- Prior allogeneic stem cell transplantation or recent autologous transplantation
- Previous use of Golidocitinib or Pomalidomide
- Current use of vitamin K antagonists, antiplatelet, or anticoagulant drugs that cannot be stopped
- Recent systemic glucocorticoid or immunosuppressive therapy except allowed forms
- Recent cytotoxic chemotherapy, systemic antineoplastic therapy, major surgery, trauma, or radiation therapy
- Receipt of other toxin/immune antibody conjugates or experimental drugs recently
- Receipt of live vaccines (except attenuated influenza) within 28 days
- Active infections including tuberculosis, HIV, active hepatitis B or C requiring treatment, other viral or bacterial infections
- Active autoimmune diseases requiring systemic treatment within past 2 years
- Uncontrolled heart conditions or significant arrhythmias
- Prior interstitial lung disease (except asymptomatic radiation-induced)
- Unresolved adverse drug reactions above grade 1 (excluding hair loss)
- Hypersensitivity to study drugs or monoclonal antibodies
- Conditions impairing drug absorption
- Pregnancy, lactation, or unwillingness to use contraception
- Psychiatric illness or inability to consent
- Any condition deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Zhiming Li
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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