Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 23
- 主要终点
- Morphologic complete response
研究概览
简要总结
The MIR study proved the effect of Rituximab in combination with a localized irradiation given in a standard dose. Together with the TROG 99.03 trial, this led to the recommendation of using this combined approach in early stage nodal follicular lymphoma. The GAZAI study is currently looking for the effect of a low dose radiotherapy of 2x2 Gy in combination with Obinutuzumab. The combination seems to show a high CR rate based on the 50% of the patients. This is in contrast to the FORT trial, which showed an inferiority of the 4 Gy dose compared to the standard dose (24 Gy) in terms of response and progression free survival.
The goal of the FORTplus trial is to prove (1) the non-inferiority of LDRT (4Gy) in a combined approach with an anti-CD20-antibody. In case of non-inferiority, a possible (2) superiority of the Obinutuzumab + LDRT should be tested against Rituximab + standard dose using the same test set.
The radiation dose can significantly be reduced to 16% of the standard dose if (1) is confirmed. Knowing the data of the FORT trial, this would have a significant influence on the treatment of the disease worldwide even if the difference in the CR rate at week 18 is not as high as currently in the historical comparison expected.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Centrally reviewed CD20-positive follicular lymphoma grade 1/2 or 3a based on WHO classification (2008)
- •Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)
- •Age: ≥18 years
- •ECOG: 0-2
- •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
- •Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter
排除标准
- •Extra nodal manifestation of follicular lymphoma
- •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
- •AST or ALT > 2.5 × ULN
- •Total bilirubin ≥ 1.5 × ULN
- •INR > 1.5 × ULN
- •PTT or aPTT > 1.5 × the ULN
研究组 & 干预措施
Standard
Standard dose (24 Gy) involved site radiotherapy plus Rituximab
干预措施: Standard (Drug)
Experimental
ow-dose (4 Gy) involved site radiotherapy in combination with Obinutuzumab
干预措施: Experimental (Drug)
结局指标
主要结局
Morphologic complete response
时间窗: Week 18
Rate of morphologic complete response based on CT scan in patients with initially remaining lymphoma
次要结局
- Metabolic complete response(week 18)
- Morphologic response(Month 6)
- PFS(2 years)
- Frequency and extent of Toxicity(until month 30)
- Overall survival(2 years)
研究者
Klaus Herfarth, MD
Vice Chair, Department of Radiation Oncology
Heidelberg University