A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
1 other identifier
interventional
116
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2026
CompletedNovember 9, 2022
November 1, 2022
1.5 years
September 25, 2022
November 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Secondary Outcomes (5)
Complete response rate
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Progression-free survival
Baseline up to data cut-off (up to approximately 2 years)
Overall survival
Baseline up to data cut-off (up to approximately 2 years)
Duration of response
Baseline up to data cut-off (up to approximately 2 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
From enrollment to study completion, a maximum of 4 years
Study Arms (4)
T1 subtypes based on next generation sequencing results
EXPERIMENTALT1 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
EXPERIMENTALT2 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
EXPERIMENTALT3.1 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
EXPERIMENTALT3.2 subtypes based on next generation sequencing results
Interventions
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Eligibility Criteria
You may qualify if:
- Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)
- Relapsed or refractory disease after first line treatment
- Availability of archival or freshly collected tumor tissue before study enrollment
- Evaluable lesion by PET-CT or CT scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy greater than or equal to (\>/=) 3 months
- Informed consent
You may not qualify if:
- Patients with central nervous system (CNS) lymphoma
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- 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.
- HIV-infected patients
- Active hepatitis infection
- Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- Pregnant or lactation
- Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weili Zhao
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- First Deputy Director, Hematology Department
Study Record Dates
First Submitted
September 25, 2022
First Posted
September 29, 2022
Study Start
September 30, 2022
Primary Completion
March 26, 2024
Study Completion
January 26, 2026
Last Updated
November 9, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share