EUCTR2014-004794-16-IT进行中（未招募）1 期
An open label multicenter Phase Ib/II trial to determine the dose of BI836826 in combination with gemcitabine and oxaliplatin (GemOx) and theefficacy of BI 836826-GemOx versus rituximab (R)- in combination withGemOx (R-GemOx) in patients with relapsed/ refractory diffuse large Bcelllymphoma (DLBCL) who are not eligible for, or have failed autologousstem cell transplant -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 35 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •- Age 18 years or older
- •- Patients with histologically confirmed, relapsed/refractory, diffuse
- •large B-cell lymphoma (including transformed follicular lymphoma) who
- •have received an anti-CD20-supplemented, anthracycline-containing
- •chemotherapy and are not eligible for high dose therapy followed by an
- •autologous stem cell transplant, or have failed autologous stem cell
- •transplant Previous allogenic stem cell transplant is allowed if patients
- •do not require immunosuppressive treatment for at least 8 weeks prior
- •to enrollment in the trial and have no evidence of active graft-versushost
- •- Patient has not received anti-lymphoma treatment prior to the first
- •dose of trial medication: within past 14 days or within time that is
- •shorter or equal to 5 half-lives of the drug if the last anti-lymphoma
- •treatment contained an investigational agent
- •- Screening computer tomography (CT) scan with involvement of 2 or
- •more clearly demarcated lesions/nodes with a long axis >1.5cm
- •- Screening [18F] flourodeoxyglucose (FDG)- positron emission tomography (PET) scans must demonstrate positive lesion compatible
- •with computer tomography (CT) defined anatomical tumor sites
- •- ECOG performance status 0, 1, 2
- •- Written signed informed consent consistent with ICH GCP and local
- •legislation
- •- Patients must have an acceptable organ function
- •- Women of childbearing potential must be ready and able to use highly
- •effective methods of birth control per ICH M3(R2) that result in a low
- •failure rate of less than 1% per year when used consistently and
- •correctly. A list of contraception methods meeting these criteria is
- •provided in the patient information. Male patients having a partner of
- •childbearing potential must use condoms and ensure their partner is
- •using a highly effective method of birth control as described above,
- •during the trial and for at least 12 months after the end of 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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 128
排除标准
- •- Eligible for curative salvage high dose therapy followed by stem cell
- •- Primary central nervous system lymphoma or known Central nervous
- •system (CNS) involvement
- •- Prior history of malignancy other than DLBCL except basal cell or
- •squamous cell carcinoma of the skin, or carcinoma in situ of the uterine
- •cervix or breast which has been treated with curative therapy. Other
- •prior malignancies are allowed only if patient has been free of disease
- •and without treatment other than hormones for at least past three years.
- •- Refractory to gemcitabine and/or oxaliplatin
- •- Contraindications for gemcitabine, oxaliplatin and/or rituximab as
- •judged by the investigator. Hypersensitivity to oxaliplatin
- •- Unresolved toxicity of CTCAE grade > 1from prior therapy (except
- •- Significant concurrent medical disease or condition which according to
- •the investigators judgment would either compromise patient safety or
- •interfere with the evaluation of the safety of the test drug. e.g.
- •symptomatic congestive heart failure, unstable angina pectoris, cardiac
- •arrhythmia requiring therapy with the exception of extra systoles of
- •minor conduction abnormalities
- •- An infection requiring treatment at the start of the trial medication.
- •- Hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •infection with positive test results from the virology screening
- •- Women who are pregnant, nursing, or who plan to become pregnant
- •while in the trial
- •- Known alcohol or drug abuse which could potentially interfere with
- •trial participation according to investigator¿s judgment
- •- Prior treatment with CD37 antibody
研究者
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