A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
NCT ID: NCT05559008
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2022-09-30
2026-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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T1 subtypes based on next generation sequencing results
T1 subtypes based on next generation sequencing results
Azacitidine Injection
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Dasatinib
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
T2 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
Azacitidine Injection
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Linperlisib
Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
T3.1 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
Tucidinostat
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
SHR2554
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
T3.2 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
Camrelizumab
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Apatinib
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Interventions
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Azacitidine Injection
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Dasatinib
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Linperlisib
Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
Tucidinostat
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
SHR2554
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Camrelizumab
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Apatinib
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director, Hematology Department
Principal Investigators
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Weili Zhao
Role: STUDY_CHAIR
Ruijin Hospital
Locations
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PTCL-IIT-umbrella
Identifier Type: -
Identifier Source: org_study_id
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