Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
NCT Number: NCT07724782
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Tianjin, Tianjin Municipality, 300060, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;
Exclusion criteria
Zeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx
Time frame: At the end of Cycle 1 (each cycle is 21 days)
A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design
Time frame: Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
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 (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 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 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 3 years after EZH2+JAK1/GemOx (Day 1)
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 2 years after EZH2+JAK1/GemOx (Day 1)
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
Contact information is provided by the study sponsor or research team.
Tianjin Medical University Cancer Institute and Hospital
Other
A Multi Cohort Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat Combination Regimen in Relapsed/Refractory Peripheral T Cell Lymphoma
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