EUCTR2005-005144-62-DE进行中（未招募）1 期
Efficacy and safety of Rituximab, high-dose ARA-C and Dexamethasone (R-HAD) alone or in combination with Bortezomib in patients with relapsed or refractory mantle cell lymphoma A randomized Phase III Trial of the European MCL Network - R-HAD
Klinikum der Ludwigs-Maximilians-Universität München0 个研究点目标入组 175 人开始时间: 2010年10月26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
- 175
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
- •Each subject must fulfill all of the following inclusion criteria before enrollment to the study:
- •- Confirmed pathological diagnosis of MCL according to WHO classification.
- •- Relapse or progression following 1 to 3 prior lines of anti-neoplastic standard therapy. Therapy in remission after initial induction like intensified chemotherapy for stem cell separation followed by myeloablative therapy or any kind of maintenance therapy is classified as one line of therapy with the induction therapy
- •- If Rituximab was part of prior induction treatment, documented time to progression must be at least 12 weeks after this particular regimen.
- •- If high-dose Ara-C was part of prior treatment, documented time to progression must be at least 6 months after this particular regimen.
- •- Patients relapsed after autologous stem cell transplantation or not appropriate for myeloablative treatment.
- •- At least 1 measurable or assessable site of disease; in case of bone marrow infiltration only, bone marrow aspiration/ biospy is mandatory for all staging evaluations.
- •- age > 18 years
- •- ECOG/WHO Performance Score 0-2, unless lymphoma related.
- •- The following laboratory values at screening, unless lymphoma related:
- •- Absolute neutrophil count (ANC) >1500 cells/µL
- •- Platelets >100,000 cells/µL
- •- Transaminases (AST and ALT) <3 x upper limit of normal (ULN)
- •- Total bilirubin < 2 x ULN
- •- Creatinine <2 mg/dL or calculated creatinine clearance > 50 mL/min
- •- Toxic effects of previous therapy or surgery resolved to NCI CTC grade 2 or better.
- •- Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •- Written informed consent before performance of any study-related procedure.
- •- Men must agree not to father a child for the duration of therapy and must agree to advice a female partner to use a highly effective method of birth control
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- •- Treatment within another clinical trial within 30 days before trial entry or planed during this trial.
- •- Anti-neoplastic (including radiation and antibody treatment) or experimental therapy within 4 weeks before planed Day 1 of Cycle 1 (Nitrosoureas within 6 weeks ) or radioimmunoconjugates or toxin immunoconjugates such as Ibritumomab tiuxetan (Zevalin™) or Tositumomab (Bexxar®) within 12 weeks before Day 1 of Cycle 1.
- •- Known hypersensitivity to Rituximab, boron or mannitol.
- •- Active malignancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy.
- •- Active systemic infection requiring treatment.
- •- HIV, hepatitis B or C
- •- Patient has > grade 2 peripheral sensory neuropathy or neuropathic pain defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE).
- •- Symptomatic degenerative or toxic encephalopathy.
- •- Serious medical condition (such as severe hepatic impairment, perdicardial disease, acute diffuse infiltrative pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study.
- •- Female subject is pregnant or breast-feeding (pregnancy testing is mandatory for premenopausal women).
研究者
相似试验
Unknown
3 期
Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCLMantle Cell LymphomaNCT01449344Prof. Dr. M. Dreyling (co-chairman)128
已完成
2 期
The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical TrialChronic Inflammatory Demyelinating PolyneuropathyJPRN-UMIN000035753agoya University Hospital27
已完成
2 期
RECIPE TrialChronic Inflammatory Demyelinating PolyneuropathyJPRN-jRCT2041180037Iijima Masahiro25
进行中（未招募）
1 期
Study of efficacy of consolidation immunotherapy with rituximab at high dose in patients with chronic lymphocytic leukemia who do not achieve complete eradication of their disease after standard treatmentPatients with B-cell CLL who (1) fail to achieve eradication of minimal residual disease (MRD) after standard treatment (immunochemotherapy) of their disease, (2) who have recurrence of MRD at any time after standard immunochemotherapyMedDRA version: 17.1Level: LLTClassification code 10068919Term: B-cell chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2011-005174-27-BECliniques universitaires Saint Luc6
进行中（未招募）
1 期
Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitisEUCTR2018-000637-12-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)106