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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
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
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGOverall response rate
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)
Complete response rate
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)
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.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival
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)
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
Time frame: 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
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.
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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
Time frame: From enrollment to study completion, a maximum of 4 years