A Phase 1/2 interventional study of Azacitidine Injection and Dasatinib in Peripheral T Cell Lymphoma, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Ruijin Hospital · Phase 1/2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 116 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
T1 subtypes based on next generation sequencing results
Drug: Azacitidine Injection · Drug: Dasatinib
T2 subtypes based on next generation sequencing results
Drug: Azacitidine Injection · Drug: Linperlisib
T3.1 subtypes based on next generation sequencing results
Drug: Tucidinostat · Drug: SHR2554
T3.2 subtypes based on next generation sequencing results
Drug: Camrelizumab · Drug: Apatinib
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
Overall 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.
Time frame: From enrollment to study completion, a maximum of 4 years
Plan to share: No
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Ruijin Hospital