This is a single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Zeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Summary of DLT events (Phase Ib)
A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Overall response rate (Phase Ⅱ)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment EZH2+JAK1/GeMox
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Complete response rate
Complete Response Rate (CRR) is defined as the proportion of subjects who achieve CR after treatment EZH2+JAK1/GeMox
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Duration of response
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders.
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis 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: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first
Time frame: Through study completion, an average of 3 years after EZH2+JAK1/GemOx (Day 1)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
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: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
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