EUCTR2011-002908-33-SK进行中（未招募）不适用
A randomized, double-blind, multi-center, multi-national Phase III trial to compare efficacy and safety of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular non-Hodgkin’s lymphoma.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female patients, at least 18 years of age at Screening.
- •- Untreated, histologically confirmed, stage III or IV NHL (CD20+ Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemotherapy).
- •- Patients not previously treated. Eligible patients previously on watch and wait (i.e., those patients who do not require treatment upfront at the time of the diagnosis) can enter the trial.
- •- ECOG performance status of 0 to 2.
- •- Have at least one measurable lesion as per the IWG criteria 2007 at Screening.
- •- Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization, including:
- •Hemoglobin = 9.0 g/dL (= 5.6 mmol/L).
- •Absolute neutrophil count = 1.5 x 109/L.
- •Platelet count = 100 x 109/L.
- •- Adequate renal and liver function
- •- For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •- Transformation to high-grade lymphoma (secondary to low grade lymphoma).
- •- Presence or history of central nervous system (CNS) lymphoma.
- •- Patients receiving current treatment with oral corticosteroids must not be receiving a dose exceeding 20 mg/day prednisone or equivalent.
- •- Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, idarubicin and/or other anthracyclines and anthracenediones.
- •- Patients with prior or concomitant malignancies.
- •- Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.
- •- Poor renal function: serum creatinine > 2.0 mg/dL (> 197 mcmol/L).
- •- Poor hepatic function: total bilirubin > 2.0 mg/dL (> 34 mcmol/L) or aspartate aminotransferase (AST) > 3 times the upper limit of normal.
- •- Active, chronic or persistent infection that might worsen with immunosuppressive treatment.
- •- Patients known to be seropositive for HBV or have active HBV infection.
- •- Serious underlying medical conditions, which per the investigator's discretion could impair the ability of the patient to participate in the trial.
- •- Patients with uncontrolled hypertension.
- •- Known sensitivity or allergy to murine products.
- •- History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug.
- •- Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.
- •- Treatment within a clinical trial within 4 weeks prior initiation of trial treatment.
- •- Refusal from patients with reproductive potential (males and females), of use of a medically acceptable method of contraception during the trial, i.e., a combination of two forms of effective contraception.
- •- Pregnancy or breast feeding
研究者
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