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Trial Title:
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
NCT ID:
NCT05559008
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Azacitidine
Apatinib
Dasatinib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine Injection
Description:
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Arm group label:
T1 subtypes based on next generation sequencing results
Arm group label:
T2 subtypes based on next generation sequencing results
Intervention type:
Drug
Intervention name:
Dasatinib
Description:
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Arm group label:
T1 subtypes based on next generation sequencing results
Intervention type:
Drug
Intervention name:
Linperlisib
Description:
Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
Arm group label:
T2 subtypes based on next generation sequencing results
Intervention type:
Drug
Intervention name:
Tucidinostat
Description:
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Arm group label:
T3.1 subtypes based on next generation sequencing results
Intervention type:
Drug
Intervention name:
SHR2554
Description:
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Arm group label:
T3.1 subtypes based on next generation sequencing results
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Arm group label:
T3.2 subtypes based on next generation sequencing results
Intervention type:
Drug
Intervention name:
Apatinib
Description:
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Arm group label:
T3.2 subtypes based on next generation sequencing results
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao, M.D. and Ph.D
Phone:
13512112076
Email:
zhao.weili@yahoo.com
Start date:
September 30, 2022
Completion date:
January 26, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05559008
