Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall response rate during prolgolimab monotherapy
研究概览
简要总结
Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).
The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
- •Age 18-70 y
- •Ejection fraction not less than 50%
- •No severe concurrent illness
- •0-2 ECOG status
- •Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug.
排除标准
- •Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;
- •Respiratory failure > grade 1 at the time of enrollment
- •Requirement for vasopressor support at the time of enrollment
- •Uncontrolled bacterial or fungal infection at the time of enrollment
- •Active or prior documented autoimmune disease requiring systemic treatment
- •Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
- •Hypersensitivity or allergy to study drugs
- •Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
- •Simultaneous use of drugs or medical devices studied in other clinical trials
- •Use of PD-1 inhibitors or bendamustine in the 1st line of therapy
研究组 & 干预措施
Main arm
Patients receive 6 cycles of prolgolimab monotherapy with subsequent assessment of response by PET/CT using Lugano and LYRIC criteria. Patients with complete response continue prolgolimab therapy for up to 24 cycles. Patients are switched to combination therapy with prolgolimab and chemotherapy (bendamustine) if the complete response is not achieved after 6 cycles of therapy or in case of relapse during prolgolimab monotherapy.
Patients without complete response after 6 cycles of prolgolimab monotherapy or with relapse during monotherapy will receive 3 cycles of combination therapy with prolgolimab and bendamustine every 28 days. Collection of hematopoietic stem cells is performed at any stage of combination therapy. Response evaluation after 3 cycles of combination therapy is performed by PET/CT using Lugano and LYRIC criteria. Autologous stem cell transplantation is conducted in patients who achieve complete or partial response.
干预措施: Prolgolimab (Drug)
Main arm
Patients receive 6 cycles of prolgolimab monotherapy with subsequent assessment of response by PET/CT using Lugano and LYRIC criteria. Patients with complete response continue prolgolimab therapy for up to 24 cycles. Patients are switched to combination therapy with prolgolimab and chemotherapy (bendamustine) if the complete response is not achieved after 6 cycles of therapy or in case of relapse during prolgolimab monotherapy.
Patients without complete response after 6 cycles of prolgolimab monotherapy or with relapse during monotherapy will receive 3 cycles of combination therapy with prolgolimab and bendamustine every 28 days. Collection of hematopoietic stem cells is performed at any stage of combination therapy. Response evaluation after 3 cycles of combination therapy is performed by PET/CT using Lugano and LYRIC criteria. Autologous stem cell transplantation is conducted in patients who achieve complete or partial response.
干预措施: Combination with prolgolimab and bendamustine (Drug)
结局指标
主要结局
Overall response rate during prolgolimab monotherapy
时间窗: 12 months
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria
次要结局
- Duration of response(24 months)
- Overall response rate during combination therapy (prolgolimab+bendamustine)(24 months)
- 1-year and 2-year overall survival(24 months)
- Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy(12 months)
- Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)(24 months)
- 1-year and 2-year progression-free survival(24 months)
研究者
Ivan S Moiseev
Vice-director for science RM Gorbacheva Institute
St. Petersburg State Pavlov Medical University