2023-509278-41-00招募中3 期
Early Stage Follicular LymphOma and RadioTherapy PLUS anti-CD20 Antibody
Universitaetsklinikum Heidelberg AöR14 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年1月25日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 14
- 主要终点
- Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)
研究概览
简要总结
Evaluation of the rate of morphologic CR in week 18 after standard dose (24 Gy) involved site (IS) radiotherapy (RT) plus Rituximab or low-dose (4 Gy) IS RT in combination with Obinutuzumab in early stage nodal follicular lymphoma (centrally reviewed)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2016)
- •Adequate contraception for men and women of childbearing age during therapy and 18 months thereafter
- •Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)
- •Age: ≥18 years
- •Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging
- •Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)
- •Written informed consent and willingness to cooperate during the course of the trial
- •Adequate bone marrow capacity: ANC ≥ 1.5 x 103/ml, thrombocytes ≥ 100000 x 10 3/ml, hemoglobin ≥ 10 g/dL
- •Capability to understand the intention and the consequences of the clinical trial
排除标准
- •Extra nodal manifestation of follicular lymphoma
- •AST or ALT > 2.5 × ULN
- •Total bilirubin ≥ 1.5 × ULN
- •INR > 1.5 × ULN
- •PTT or aPTT > 1.5 × the ULN
- •Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed >3 years ago)
- •Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease
- •Severe psychiatric disease
- •Pregnancy / lactation
- •Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug
- •Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)
- •Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial
- •Creatinine > 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance < 40 mL/min
结局指标
主要结局
Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)
Morphologic complete response (CR) in week 18 in patients with remaining macroscopic PET positive lymphoma after initial diagnostic biopsy judged by CT (centrally reviewed)
次要结局
- Morphologic CR, PR, SD, PD in week 7 and month 6 in patients with initially remaining lymphoma judged by CT/MRI
- Metabolic CR in week 18 in patients with initially remaining lymphoma judged by FDGPET/ CT (centrally reviewed)
- Progression-free survival (PFS) of each treatment arm (2 years after individual treatment start)
- PFS of patients in stage I0 after diagnostic surgery (no remaining lymphoma) treated as the experimental arm (2 years after individual treatment start)
- Toxicity (NCI-CTC criteria, version 5) of all patients
- Relapse rate and pattern of recurrence of each treatment arm at all follow-up visits.
- Overall survival (OS) of each treatment arm (2 years)
- Quality of life according EORTC QLQ C30 and FACT-Lym questionnaires at inclusion and in week 18, month 12, and 24 (each treatment arm)
研究者
Prof. Dr. Klaus Herfarth
Scientific
Universitaetsklinikum Heidelberg AöR
研究点 (14)
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