Actively Recruiting
A Phase I/II Study of Golidocitinib in Combination with CHOP in Patients with Newly Diagnosed Peripheral T Cell Lymphoma
Led by Peking Union Medical College Hospital · Updated on 2024-12-18
68
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of golidocitinib combined with the CHOP chemotherapy regimen for patients newly diagnosed with peripheral T-cell lymphoma (PTCL). This single-arm phase I/II study includes two stages: phase I focuses on finding the maximum tolerated dose and recommended dose for phase II, while phase II aims to measure the complete response rate of the combination treatment. The study addresses important treatment options for PTCL, a type of lymphoma affecting certain white blood cells. The study treatment involves giving golidocitinib along with the CHOP regimen, which includes cyclophosphamide, epirubicin, vindesine, and prednisone. In phase I, two doses of golidocitinib will be tested (150 mg every other day and 150 mg daily) alongside the CHOP drugs in cycles of 21 days. Phase II will use the recommended dose from phase I with the same CHOP schedule to see how well patients respond. Each cycle involves specific intravenous and oral doses given on set days. Participants will be closely monitored throughout the study with evaluations after three cycles of treatment and one month after completing therapy. Researchers will assess response rates, progression-free survival, overall survival, and document any side effects during and after treatment. The study follow-up may continue up to three years to track these outcomes and ensure patient safety. The total duration includes treatment cycles plus extended monitoring of health and disease status.
CONDITIONS
Brief Title
Golidocitinib Plus CHOP in Newly Diagnosed PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Histopathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) of specified subtypes including PTCL-NOS, AITL, ALCL, or other eligible PTCL subtypes
- At least one measurable lesion according to Lugano 2014 criteria (lymph node >1.5 cm or extranodal lesion >1.0 cm)
- ECOG performance status score between 0 and 3
- Adequate bone marrow function with specified minimum counts (ANC, PLT, HGB) with some relaxation for bone marrow involvement
- Adequate organ function including ALT, TBIL, creatinine clearance, and left ventricular ejection fraction within defined limits
You will not qualify if you...
- Diagnosis of extranodal NK/T-cell lymphoma
- History of recent serious heart conditions including myocardial infarction, unstable angina, congestive heart failure, arrhythmias, or significant QT prolongation within 6 months
- Uncontrolled active infection
- Severe blood count or organ function abnormalities beyond defined thresholds
- Presence of primary or secondary central nervous system lymphoma at enrollment
- Pregnant or breastfeeding women
- Receipt of any investigational drug or radiotherapy within the past 4 weeks
- Individuals considered unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction with 3 cycles of 3 weeks each, followed by evaluation and additional treatment as determined by study phase and response
Participants receive Golidocitinib plus CHOP chemotherapy in repeated 3-week cycles. Treatment includes intravenous and oral medications as per the study regimen.
At least 3 cycles with visits every 3 weeks for treatment and assessment
Duration - Up to 3 years post treatment
Participants are monitored for adverse events and treatment response for up to 28 days after the last induction cycle, with survival follow-up extending up to 3 years.
Periodic follow-up visits for safety and survival assessments
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
W
Wei Zhang, Dr
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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