2024-515064-31-00
招募中
2 期
Use of nivolumab (N) followed by chemotherapy: bendamustine, gemcitabine and dexamethasone (BGD) with autologous bone marrow transplantation in patients with Hodgkin’s lymphoma refractory to 1-line therapy.
相关药物NIVOLUMAB
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Medical University Of Gdansk
- 入组人数
- 84
- 试验地点
- 8
- 主要终点
- Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N).
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
To evaluate the efficacy and safety of the intervention based on early initiation of second-line treatment (Nivolumab) in patients with Hodgkin's lymphoma resistant to previously administered treatment, followed by BGD chemotherapy (2 cycles) and consolidation with autologous transplantation of hematopoietic stem cells (aHCT). Additionally, the predictive value of circulating free DNA of Hodgkin's lymphoma cells measured before autologous transplantation will be assessed.
研究者
Study Coordinator
Scientific
Medical University Of Gdansk
入排标准
入选标准
- •Patients with recurrence of previously confirmed histopathologically confirmed classical Hodgkin's lymphoma based on the local pathology report according to the WHO 2016 classification, after the first line of treatment initially diagnosed in stage IIA but with a large metabolic tumor volume or the presence of a massive lesion (>10cm) or diagnosed in stage IIB- IV OR Patients with primary refractory classical Hodgkin's lymphoma in stage IIA with a large metabolic tumor volume (>147 ml) or the presence of a massive lesion (>10 cm) or in stage IIB-IV. Primary resistance to treatment will be defined by a positive iPET2 test (Deauville scale scores 4 and 5) performed after the 2nd cycle of first-line chemotherapy; and in patients with a negative iPET2 test result (Deauville scale scores 1, 2, 3) the occurrence of active disease confirmed by PET-CT within three months of the end of first-line chemotherapy.
- •Evaluation of disease advancement by PET examination at diagnosis.
- •Age ≥18 years old
- •Presence of at least one measurable change
- •Consent to effective contraception during the study using contraception for 14 months for women and 11 months for men after the last dose of immuno-chemotherapy
- •In women of childbearing age, a negative serum pregnancy test result at screening and consent to use highly effective methods of contraception during the study and for 14 months after the last dose of chemotherapy (except for patients over 50 years of age with natural amenorrhea for a period of at least 12 months or after bilateral salpingoophorectomy or hysterectomy).
- •Signing consent to participate in the clinical trial
排除标准
- •Non-classical form of Hodgkin's lymphoma
- •Liver failure (bilirubin 1.5 x ULN, SGOT > 5 x ULN) if unrelated to lymphoma, and Gilbert's syndrome
- •HIV infection, active HBV, HCV, CMV infection. In the case of hepatitis B infection and the presence of abHBc, it is necessary to evaluate the PCR DNA of the virus and start prophylactic treatment in accordance with the advice of an infectious disease doctor.
- •Pregnancy or breastfeeding
- •Known hypersensitivity to any of the drugs used in the treatment.
- •The patient is unable to sign the informed consent form to participate in the study.
- •Performance status according to ECOG>2
- •Failure to perform PET scans during induction treatment in accordance with the inclusion criteria
- •Transformation of Hodgkin's lymphoma into another lymphoma
- •Central nervous system involvement
结局指标
主要结局
Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N).
Complete Metabolic Remission (CMR) rate after 2 cycles of BGD preceded by 3 administrations of Nivolumab (N).
PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause.
PFS, which is the time from N treatment initiation to progression (PD) or death, regardless of cause.
次要结局
- Percentage of all complete and partial metabolic responses (overall metabolic response rate, OMRR = CMR + CSF after N, BGD, and aHCT treatment.
- Overall Survival (OS) from the time of initiation of Nivolumab treatment to the time of death from any cause.
- Percentage of patients among whom aHCT was successfully performed.
- Tolerance of N-BGD treatment defined as the frequency of adverse events (AEs) with a toxicity level greater than two based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
- The number of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.
研究点 (8)
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