Actively Recruiting
Genotype-guided Treatment in Newly Diagnosed PTCL
Led by Ruijin Hospital · Updated on 2024-01-08
264
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
T
The First Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study includes Phase I and Phase II stages. Phase I is an open-label trial to confirm RP2D of oral targeted agents in three genetic subtypes. Phase II is a multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.
CONDITIONS
Official Title
Genotype-guided Treatment in Newly Diagnosed PTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed Peripheral T-cell lymphoma
- Availability of archival or freshly collected tumor tissue before study enrollment sufficient for next-generation sequencing
- Presence of evaluable lesion by PET-CT or CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy of at least 3 months
- Signed informed consent
You will not qualify if you...
- Patients with anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma
- Patients with central nervous system lymphoma
- History of other malignancies except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Uncontrolled cardiovascular or cerebrovascular diseases, blood clotting disorders, connective tissue diseases, serious infections, or other serious illnesses
- Laboratory abnormalities: neutrophils less than 1.0 x 10^9/L, platelets less than 75 x 10^9/L (or less than 50 x 10^9/L if bone marrow involved), ALT or AST more than 2.5 times upper limits of normal, AKP and bilirubin more than 1.5 times upper limits, creatinine more than 1.5 times upper limits
- HIV infection
- Active hepatitis infection
- Psychiatric disorders or inability to comply with study protocol
- Pregnant or breastfeeding
- Other medical conditions that may affect study participation
- For T3 genetic subtype: active autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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