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

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Peripheral T Cell Lymphoma

Treatments: Drug: Apatinib; Drug: Azacitidine Injection; Drug: SHR2554; Drug: Dasatinib; Drug: Linperlisib; Drug: Camrelizumab; Drug: Tucidinostat

Study type: Interventional

Funder types: Other

Identifiers

NCT05559008

PTCL-IIT-umbrella

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 4 patient groups

T1 subtypes based on next generation sequencing results

Experimental group

Description:

T1 subtypes based on next generation sequencing results

Treatment:

Drug: Dasatinib

Drug: Azacitidine Injection

T2 subtypes based on next generation sequencing results

Experimental group

Description:

T2 subtypes based on next generation sequencing results

Treatment:

Drug: Linperlisib

Drug: Azacitidine Injection

T3.1 subtypes based on next generation sequencing results

Experimental group

Description:

T3.1 subtypes based on next generation sequencing results

Treatment:

Drug: Tucidinostat

Drug: SHR2554

T3.2 subtypes based on next generation sequencing results

Experimental group

Description:

T3.2 subtypes based on next generation sequencing results

Treatment:

Drug: Camrelizumab

Drug: Apatinib