A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Overall response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
T1 subtypes based on next generation sequencing results
T1 subtypes based on next generation sequencing results
Intervention: Azacitidine Injection (Drug)
T1 subtypes based on next generation sequencing results
T1 subtypes based on next generation sequencing results
Intervention: Dasatinib (Drug)
T2 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
Intervention: Linperlisib (Drug)
T2 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
Intervention: Azacitidine Injection (Drug)
T3.1 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
Intervention: Tucidinostat (Drug)
T3.1 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
Intervention: SHR2554 (Drug)
T3.2 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
Intervention: Camrelizumab (Drug)
T3.2 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
Intervention: Apatinib (Drug)
Outcomes
Primary Outcomes
Overall response rate
Time Frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Secondary Outcomes
- 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)
Investigators
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital