Randomized Study Comparing AVD Combined With Fixed-Dose Nivolumab Versus PET-Adapted BEACOPP-like Regimen as First-Line Treatment in Advanced Classical Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
Patients in this prospective multicenter phase II study will be randomized between two first-line therapy strategies for advanced stages of cHL. In the Nivo-AVD cohort, patients will receive 2 cycles of nivolumab monotherapy followed by a switch to Nivo-AVD combination therapy (total of 6 cycles); in the Standard cohort, patients will receive therapy according to current clinical guidelines in Russian Federation for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to A(B)VD or continuing with BEACOPP-like regimens
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed histologically confirmed stage IIB, III or IV classical hodgkin lymphoma who have not previously received specific therapy;
- •Patients with evidence of lesion extent assessed by whole-body PET/CT;
- •Patients aged 18-60 years;
- •ECOG 0-2;
- •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
研究组 & 干预措施
Nivo-AVD
Nivo-AVD cohort patients will receive 2 cycles of nivolumab monotherapy (40 mg) followed by Nivo-AVD combination therapy (6 cycles total)
干预措施: Nivo-AVD (Drug)
BEACOPP-like regimes - Standard cohort
In the Standard cohort, patients will receive therapy according to current clinical guidelines for first-line therapy of cHL, which include starting first-line therapy with 2 cycles of BEACOPP-like regimens and, after assessing response after 2 courses, switching to an A(B)VD regimen (when achieving CR by PET/CT) or continuing therapy with BEACOPP-like regimens (when achieving PR,SD by PET/CT)
干预措施: BEACOPP-like (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 24 months from thetreatment start
To compare the safety of therapy use in the Nivo-AVD and Standard cohorts: analysis of the incidence, severity and spectrum of adverse events (according to CTCAE v5.0 criteria)
次要结局
- Progression-free survival(12, 24 and 36 months after completion of therapy)
- Response rates(after 2 cycles of nivo and 2 cycles of Nivo-AVD (3 months from therapy initiation) and at the end of treatment (7 months from therapy initiation) and, in Standard cohorts, after 2 cycles and EOT of BEACOPPesc (2 and 6 months))
- Overall survival(12, 24, and 36 months after completion of therapy)
研究者
Ivan S Moiseev
Vice-director of RM Gorbacheva Research Institute
St. Petersburg State Pavlov Medical University