A Phase II Trial of Tazemetostat Plus Mosunetuzumab in Untreated Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants who achieve a complete response (CR) by completion of therapy, as determined by the Lugano Criteria
研究概览
简要总结
The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety.
Tazemetostat is a drug that inhibits EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system's ability to fight it. Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas.
Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma, called immunotherapy. Bispecific antibodies have two ends: one attaches to T cells in the immune system and the other attaches to lymphoma cells, helping guide our immune system to attack the cancer. Mosunetuzumab has been studied in follicular lymphoma that has previously been treated, with positive results. Mosunetuzumab is approved by the FDA to be given intravenously (directly into a vein) but is not yet approved by the FDA is not yet approved as an injection under the skin, which is how it is given in this study. They have not yet been studied in combination.
详细描述
This is a phase II, open-label study. Fifty patients will be enrolled and treated with standard dosing of SC mosunetuzumab, and with oral tazemetostat by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation. Response assessments by PET/CT will occur post-mosunetuzumab at Cycle 4, Day 1 (+/- 3 days) and again at the end of treatment. If a participant has a complete response (CR) at Cycle 4 and/or cycle 8, then they will receive a total of 8 cycles of mosunetuzumab. If the patient has a partial response or stable disease at Cycle 4 and Cycle 8, then they will receive a total of 12 cycles of mosunetuzumab. All participants will receive 12 cycles of tazemetostat, unless discontinued from treatment early for disease progression or other protocol-defined reasons. Treatment with steroids, tocilizumab, growth factors, tumor lysis prophylaxis, and antibiotics may be used as per standard of care at our institution. Dose modifications are permitted for toxicity. Correlative studies will be performed prior to and following tazemetostat treatment and peripheral blood collections prior to post-mosunetuzumab treatment, which will give additional descriptive data for use in correlative analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subcutaneous Mosunetuzumab and Oral Tazemetostat
50 patients will be enrolled and treated with standard dosing of subcutaneous mosunetuzumab, and with oral tazemetostat by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation.
干预措施: Mosunetuzumab (Drug)
Subcutaneous Mosunetuzumab and Oral Tazemetostat
50 patients will be enrolled and treated with standard dosing of subcutaneous mosunetuzumab, and with oral tazemetostat by mouth twice daily at standard dosing (800 mg twice daily) beginning at the same time as mosunetuzumab initiation.
干预措施: Tazemetostat Pill (Drug)
结局指标
主要结局
Number of participants who achieve a complete response (CR) by completion of therapy, as determined by the Lugano Criteria
时间窗: Estimated day 336
The proportion of patients who achieve complete response as per the Lugano criteria will be calculated and their 90% confidences will be computed with Clopper-Pearson method via exact binomial distribution.
次要结局
- Number of participants who experience Immune effector cell-associated neurotoxicity syndrome (ICANS)(Day 0 to Day 28)
- Median Progression-Free Survival (PFS)(For a maximum of approximately 10 years)
- Objective Response Rate (ORR) at the time of therapy completion, as defined by Lugano Criteria(Estimated to be day 336)
- Number of participants who experience cytokine release syndrome (CRS)(Day 0 to Day 28)
- Median Overall Survival (OS)(For a maximum of approximately 10 years)
- Number of participants who achieve a Complete Response (CR) per Lugano's Criteria(For a maximum of approximately 10 years)
- Median Duration of Response(For a maximum of approximately 10 years)