EUCTR2013-004014-17-IT进行中（未招募）不适用
Phase II study with Ga101-DHAP as induction therapy in relapsed/refractoryDiffuse Large B-cell Lymphoma (DLBCL) patients before High-Dosechemotherapy BEAM with autologous stem cell transplantation (ASCT). - FIL_GA101_DHAP
Fondazione Italiana Linfomi ONLUS0 个研究点开始时间: 2014年6月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.18= Age < 65
- •2.Relapsed/refractory disease after receiving one line of standard R-CHOP like chemotherapy
- •3.Diffuse Large B-cell Lymphoma at relapse. Patient has to be re-biopsied prior study entry. This is particularly recommended if relapse is over 1 year from previous complete remission. If this is harmful for the patient, the patient can be enrolled if archivial tumor sample and block from first diagnosis are available.
- •4.Measurable and/or evaluable disease
- •5.Any Ann Arbor stage and IPI group at relapse
- •6.Performance status < 2 according to ECOG scale unless due to lymphoma
- •7.No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma)
- •8.Adequate haematological counts: ANC > 1.5 x 109/L, Hgb > 10.5 g/dl (transfusion independent), Platelet count > 75 x 109/L (transfusion independent), with the exception of cytopenia due to lymphoma bone marrow involvement
- •9.Normal liver function (ALP, AST, ALT, GGT, conjugated bilirubin total < 2 x ULN) if not related to lymphoma
- •10.Normal kidney function (creatinine clearance > 45 ml/min)
- •11.Cardiac ejection fraction > 50% (MUGA scan or echocardiography)
- •12.Normal lung function
- •13.Absence of active infections
- •14.Non peripheral neuropathy or active neurological non neoplastic disease of CNS
- •15.Non major surgical intervention prior 3 months to randomization if not due to lymphoma and/or not other disease life-threatening that can compromise chemotherapy treatment
- •16.Disease free of prior malignancies other than lymphoma for > 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- •17.Life expectancy > 6 months
- •18.No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- •19.Written informed consent
- •20.Women must be:
- •-postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
- •-surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- •-abstinent (at the discretion of the investigator/per local regulations), or
- •-if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be prepared to continue birth control measures for at least 12 months after terminating treatment.
- •21.Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening
- •22.Men must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
- •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 78
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diagnosis of Lymphoblastic Lymphoma, Burkitt Lymphoma, Non Hodgkin Lymphoma CD20 negative, Mantle Cell Lymphoma, Follicular Lymphoma, Primary Mediastinal Lymphoma
- •2.Age = 65 years
- •3.Patients ineligible to high-dose chemotherapy
- •4.Performance status > 2 according to ECOG scale if not due to lymphoma
- •5.Patients who previously received GA101 (obinutuzumab) are excluded.
- •6.Patient has known or suspected hypersensitivity or intolerance to Rituximab
- •7.Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
- •8.CNS disease (meningeal and/or brain involvement by lymphoma)
- •9.History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- •10.Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology)
- •Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo monthly DNA testing.
- •11.Positive test results for hepatitis C (HCV antibody serology testing)
- •Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- •12.Known history of HIV seropositive status
- •For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.
- •13.Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
- •14.Uncontrolled or severe cardiovascular disease including myocardial infarction within six months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- •15.Cardiac ejection fraction < 45% (MUGA scan or echocardiography)
- •16.Creatinine clearance < 45 ml/min
- •17.Presence of major neurological disorders
- •18.Active infection
- •19.Major surgical intervention prior 3 months to randomization if not due to lymphoma and/or other disease life-threatening that can compromise chemotherapy treatment
- •20.Prior malignancies other than lymphoma in the last 3 years with exception of currently treated squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- •21.Life expectancy < 6 months
- •22.Any other coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
- •23.If female, the patient is pregnant or breast-feeding.
研究者
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