Clinical Research Directory

Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma

This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type). The study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment phase and receive 1200 mg of XNW5004 tablets twice daily, with a 10-14-hour interval between doses. Each treatment cycle consists of 28 consecutive days of dosing, and pharmacokinetic (PK) blood samples will be collected at the designated time points.Safety assessments and quality-of-life (QoL) assessments will be performed in accordance with the study follow-up schedule.Tumor assessments will be conducted every 8 weeks (every 2 cycles) for the first 48 weeks after the first dose (Cycles 1 to 12), and every 12 weeks (every 3 cycles) thereafter (from Cycle 13 onward).Subjects who discontinue treatment must complete an end-of-treatment visit and safety follow-up. For long-term follow-up:Subjects who terminate treatment for reasons other than disease progression and do not initiate new antineoplastic therapy will continue tumor assessments per the original schedule until disease progression, initiation of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.For all patients (excluding those who withdraw informed consent, are lost to follow-up, or die), survival follow-up will be performed every 12 weeks (±7 days) starting from the date of the last tumor assessment, until withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.

Watch and Wait or Worry and Wait in Indolent Lymphoma

Indolent lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, low-grade follicular lymphoma, and Waldenström macroglobulinemia, are slow-growing cancers often managed initially with a watchful waiting strategy. This approach avoids unnecessary side effects of early therapy but may negatively impact patients' quality of life (QoL) due to anxiety, uncertainty, and self-monitoring of symptoms. Previous research has suggested increased distress and greater QoL decline in patients under observation compared to those receiving treatment, despite similar or lower disease burden. Moreover, poor QoL has been shown to independently predict overall survival in non-Hodgkin lymphoma patients. However, there are limited data from Asian populations, where cultural factors, health insurance systems, and treatment access differ significantly. This study will evaluate the impact of watchful waiting on patient-reported QoL among Korean patients with indolent lymphoma, providing evidence specific to this population and healthcare setting.