Actively Recruiting
Golidocitinib Plus CHOP in Newly Diagnosed PTCL
Led by Peking Union Medical College Hospital · Updated on 2024-12-18
68
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen.
CONDITIONS
Official Title
Golidocitinib Plus CHOP in Newly Diagnosed PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Confirmed diagnosis of peripheral T-cell lymphoma subtypes including PTCL-NOS, AITL, ALCL, or other investigator-approved PTCL
- At least one measurable lesion: lymph node lesion >1.5 cm or extranodal lesion >1.0 cm
- ECOG performance status between 0 and 3
- Adequate bone marrow function: ANC ≥1.5×10^9/L, PLT ≥75×10^9/L, HGB ≥90 g/L (relaxed thresholds for bone marrow involvement)
- Adequate organ function: ALT <3× ULN, total bilirubin ≤1.5× ULN, creatinine clearance ≥50 mL/min, LVEF ≥50%
You will not qualify if you...
- Diagnosis of extranodal NK/T-cell lymphoma
- History of recent (past 6 months) serious heart conditions including acute myocardial infarction, unstable angina, heart failure, arrhythmias, or significant QT prolongation (men >450 ms, women >470 ms)
- Uncontrolled active infection
- Low blood counts or impaired liver/kidney function: ANC ≤0.5×10^9/L, lymphocyte count ≤0.4×10^9/L, PLT ≤75×10^9/L, ALT ≥3× ULN, creatinine clearance <50 mL/min
- Presence of primary or secondary central nervous system lymphoma
- Pregnancy or breastfeeding
- Receipt of investigational drugs or radiotherapy within 4 weeks prior to enrollment
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
W
Wei Zhang, Dr
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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