Back to resultsA Umbrella Study in R/R PTCL Guided by Molecular Subtypes
Primary Purpose
Peripheral T Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Azacitidine Injection
Dasatinib
Linperlisib
Tucidinostat
SHR2554
Camrelizumab
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
T1 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
Arm Description
T1 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
Outcomes
Primary Outcome Measures
Overall response rate
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Secondary Outcome Measures
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Progression-free survival
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Duration of response
Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05559008
Brief Title
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
Official Title
A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
March 26, 2024 (Anticipated)
Study Completion Date
January 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T1 subtypes based on next generation sequencing results
Arm Type
Experimental
Arm Description
T1 subtypes based on next generation sequencing results
Arm Title
T2 subtypes based on next generation sequencing results
Arm Type
Experimental
Arm Description
T2 subtypes based on next generation sequencing results
Arm Title
T3.1 subtypes based on next generation sequencing results
Arm Type
Experimental
Arm Description
T3.1 subtypes based on next generation sequencing results
Arm Title
T3.2 subtypes based on next generation sequencing results
Arm Type
Experimental
Arm Description
T3.2 subtypes based on next generation sequencing results
Intervention Type
Drug
Intervention Name(s)
Azacitidine Injection
Intervention Description
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Intervention Description
Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes
Intervention Type
Drug
Intervention Name(s)
Linperlisib
Intervention Description
Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes
Intervention Type
Drug
Intervention Name(s)
Tucidinostat
Intervention Description
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Intervention Type
Drug
Intervention Name(s)
SHR2554
Intervention Description
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Camrelizumab and Apatinib will be administered in T3.2 subtypes
Primary Outcome Measure Information:
Title
Overall response rate
Description
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time Frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Complete response rate
Description
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time Frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Title
Progression-free survival
Description
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Overall survival
Description
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Duration of response
Description
Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria
Time Frame
Baseline up to data cut-off (up to approximately 2 years)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
From enrollment to study completion, a maximum of 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao
Phone
+862164370045
Ext
610707
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu
Phone
+862164370045
Ext
610707
Email
pengpeng_xu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, M.D. and Ph.D
Phone
13512112076
Email
zhao.weili@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
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