EUCTR2015-000568-32-DE进行中（未招募）1 期
Obinutuzumab containing conditioning regimen for CLL patients and patients with Richter`s transformation requiring an allogeneic stem cell transplantation
niversität Köln0 个研究点目标入组 40 人开始时间: 2016年11月1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
- 40
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
- •1.Have documented CLL according to iwCLL criteria
- •2.a) CLL requiring transplant according to the consensus statement 2014:1
- •Non-response or early relapse within 24 months after purine analogue combination therapy or treatment of similar efficacy plus high risk CLL TP53 deletion/mutation (del 17p-) and/or del 11 plus response to kinase inhibitors or other small molecules
- •Non-response or early relapse within 24 months after purine analogue combination therapy or treatment of similar efficacy and refractory to or non-tolerating kinase inhibitors or other small molecules
- •b) Transformation of CLL to aggressive NHL (Richter’s transformation)
- •The CLL patients should have at least one therapy with the newer targeted agents such as BCL-2 inhibitors or BCR targeting agents. Both poor risk CLL patients and patients with Richter`s transformation should achieve the best possible response defined as disease sensitivity measured as CR, PR or SD prior to transplant with an available salvage therapy
- •3.Availability of a suitable fully matched (10/10) sibling or unrelated donor
- •4.Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of = 1.
- •5.Hematology values within the following limits unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g. myelodysplastic syndrome 2, hypoplastic bone marrow):
- •Absolute neutrophil count = 1.0 x 109/L
- •Platelets = 50 x 109/L and more than 7 days since last transfusion
- •6.Adequate liver function as indicated by a total bilirubin AST, and ALT =1.5 the institutional ULN value, unless directly attributable to the patient’s CLL
- •7.Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative, patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 1 year after last dosage of obinutuzumab), negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration
- •8.18 years of age or older but not older then 70 years
- •9.Able and willing to provide written informed consent and to comply with the study protocol procedures
- •10.Patient agrees to inform other physicians about study participation
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •11.Previous allogeneic stem cell transplant
- •12.Known central nervous system (CNS) involvement
- •13.Patients with a history of confirmed PML
- •14.Clinically significant cardiac disease including unstable angina, acute myocardial infarction withinsix months prior to randomization, congestive heart failure (left ventricular ejection fraction < 50%).
- •15.Organ dysfunction DLCO < 50%, TLC < 70%, FEV1 < 70% and or receiving supplementary oxygen, Inadequate renal function: Creatinine clearance < 50ml/min
- •16.Patients with active fungal infections with radiological progression despite treatment with Ambisome or active Triazole for more than a month
- •17.History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products
- •18.Hypersensitivity to Obinutuzumab or to any of the excipients such as for example Mannitol
- •19.Participation in another experimental drug trial (including chemotherapy, antibody treatment, kinase inhibitors, BCL2-antagonists or immunmodulatory agents) with start of the conditioning regimen/first Obinutuzumab application.
- •20.Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)
- •21.Fertile men or women of childbearing potential unless:
- •Surgically sterile or = 2 years after the onset of menopause
- •Willing to use a highly effective contraceptive method (Pearl Index < 1) such as oral hormonal contraceptives, intrauterine device, sexual abstinence or barrier method of contraception in conjunction with spermicidal jelly during study treatment and for 12 months after end of study treatment.
- •22.Vaccination with a live vaccine a minimum of 28 days prior to randomization
- •23.Prisoners or patients who are institutionalized by regulatory or court order or persons who are in dependence to the sponsor or an investigator
研究者
相似试验
终止
2 期
Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allogeneic Stem Cell TransplantationRichter's TransformationChronic Lymphocytic LeukemiaNCT03153514German CLL Study Group3
进行中（未招募）
不适用
Study to determine the recommended dose, the safety and the efficacy of lenalidomide administered in association with obinutuzumab (GA101) for the treatment of relapsed/refractory B-cell Lymphoma.Phase IB: CD20 positive Follicular Lymphoma, WHO grade 1, 2 or 3a relapsed/refractory after =1 prior R-containing regimen Phase II: CD20 positive follicular and agressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma) relapsed/refractory after =1 prior R-containing regimenMedDRA version: 15.0Level: PTClassification code 10016906Term: Follicle centre lymphoma, follicular grade I, II, III refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.0Level: PTClassification code 10026801Term: Mantle cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005150-62-FRGELARC
进行中（未招募）
1 期
Study to determine the recommended dose, the safety and the efficacy of lenalidomide administered in association with obinutuzumab (GA101) for the treatment of relapsed/refractory B-cell Lymphoma.Phase IB: CD20 positive Follicular Lymphoma, WHO grade 1, 2 or 3a relapsed/refractory after =1 prior R-containing regimen Phase II: - CD20 positive follicular not previously treated- CD20 positive follicular relapsed/refractory after =1 prior R-containing regimen- agressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma) relapsed/refractory after =1 prior R-containing regimenMedDRA version: 21.0Level: PTClassification code 10016906Term: Follicle centre lymphoma, follicular grade I, II, III refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10026801Term: Mantle cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005150-62-BEYSARC291
进行中（未招募）
2 期
Obinutuzumab plus bendamustine therapy in patients with relapsed follicular lymphoma: a single armed,multicentre, phase 2 trialFollicular lymphomaRituximab sensitive, relapseD008224JPRN-jRCTs041190084Hirokazu Nagai50
进行中（未招募）
1 期
A phase II study of obinutuzumab monotherapy in rituximab-refractory follicular lymphomarituximab refractory follicular lymphomaMedDRA version: 16.1 Level: LLT Classification code 10016896 Term: Follicle centre lymphoma diffuse small cell lymphoma NOS System Organ Class: 100000004864EUCTR2013-004635-69-NLVU University Medical Center25