A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

• Status: Recruiting
• Trial end date: 2026-01-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Apatinib; Azacitidine; Dasatinib

Criteria

Inclusion Criteria:

1. Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)

2. Relapsed or refractory disease after first line treatment

3. Availability of archival or freshly collected tumor tissue before study enrollment

4. Evaluable lesion by PET-CT or CT scan

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

6. Life expectancy greater than or equal to (>/=) 3 months

7. Informed consent

Exclusion Criteria:

1. Patients with central nervous system (CNS) lymphoma

2. History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

3. Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases

4. Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

Neutrophils<1.0×10^9/L Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.

Creatinine is 1.5 times higher than the ULN.

5. HIV-infected patients

6. Active hepatitis infection

7. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol

8. Pregnant or lactation

9. Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease