EUCTR2015-002846-30-SE进行中（未招募）1 期
BIO-CHIC-Study BIOmarker driven and dose intensified CHemoImmunotherapy with early CNS prophylaxis in patients less than 65 years with high risk diffuse large B-cell lymphoma - BIO-CHIC
HUS-The Hospital District of Helsinki and Uusimaa0 个研究点目标入组 120 人开始时间: 2017年5月18日最近更新:
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
- 120
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
入选标准
- •Age ? 18 - < 65 years
- •Histologically confirmed CD20+ DLBCL based on revised WHO 2008 Lymphoma Classification [47]. The following subgroups and variants can
- •be included:
- •oALK-positive large B-cell lymphoma
- •oIntravascular large B-cell lymphoma
- •oT-cell rich B-cell lymphoma
- •oMyc/BCL-2 double hit lymphoma
- •oFollicular lymphomas grade 3b
- •oDLBCL with previously undiagnosed concurrent small cell infiltration in bone marrow, lymph node, or extranodal site and lymphomas
- •intermediate between DLBCL and Burkitt’s lymphoma are allowed
- •Patients in at least stage II with age adjusted IPI score of 2 or 3:
- •oStage III /IV and elevated LDH
- •oStage III/IV and WHO performance status 2 - 3
- •oStage II and elevated LDH and WHO performance status 2 – 3
- •And/or patients with site specific risk factors for CNS recurrence defined as follows
- •oMore than one extranodal site
- •oTesticular lymphoma, stage IIE and higher
- •oParanasal sinus and orbital lymphoma with destruction of bone
- •oLarge cell lymphoma infiltration of the bone marrow
- •Previously untreated, except steroids allowed
- •WHO performance status 0-3
- •Written informed consent
- •Biologically high risk group consists of patients with at least one of the following factor
- •Myc translocation (FISH)
- •Myc/Bcl2 double hits (FISH)
- •P53 deletion (FISH)
- •Myc+ and Bcl2+ (IHC; double expressors, DE)
- •P53+ (ICH)
- •CD5+ (IHC)
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Posttransplantation lymphoma (PTLD), discordant or transformed lymphoma
- •Severe cardiac disease: cardiac function grade 3-4, left ventricular ejection fraction <45%
- •?Impaired bone marrow liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment Schedule
- •(Hemoglobin < 9 g/dL, ANC < 1.5 × 109/L, Platelet count < 75 × 109/L, creatinine clearance < 40 mL/min, ALT/AST > 2.5 x ULN, Bilirubin
- •? 1.5 x ULN, INR > 1.5)
- •Pregnancy/lactation
- •Men and women of reproductive potential not agreeing to use effective contraception during treatment and for 18 months after
- •completion of treatment (Effective contraception is combined (estrogen and progestogen containing) hormonal contraception associated
- •with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of
- •ovulation (oral, injectable or implantable), intrauterine device (IUD), ihormone-releasing IUD, bilateral tubal occlusion, vasectomised
- •partner, or sexual abstinence
- •Patients with other severe medical problems, including active infections, cardiac or pulmonary disease, history of PML and with an
- •expected short survival for non-lymphoma reasons
- •Known HIV positivity
- •Active or chronic hepatitis B virus (HBV) infection (defined as positive HBsAg serology), or active hepatitis C virus (HCV) infection (defined by
- •antibody serology testing). HBsAg, HBcAb, and HCVAb must be tested during screening. Patients who have protective titers of HBsAb along
- •negative HBsAg after vaccination or prior but cured hepatitis B are eligible.
- •Vaccination with a live vaccine within one month prior to randomization
- •Patients with a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without
- •treatment for = 5 years prior to enrollment
- •Earlier treatment containing anthracyclins
- •Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
- •CNS disease as diagnosed by MRI or CSF cytology. Positive CSF flow cytometry below diagnostic threshold level by cytology is allowed
- •Transformed lymphoma
- •Primary mediastinal B-cell lymphoma
- •Pleural or peritoneal fluid that cannot be drained safely
- •Hypersensitity to the active substance or any of the other ingredients
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine
- •Patients participating in other clinical studies, unless followed for survival
- •Lower urinary tract constriction, which cannot be treated adequately
- •Degenerative and toxic encephalopathy
- •Neuromuscular disease
研究者
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