EUCTR2016-002044-16-IT进行中（未招募）1 期
A Phase 2/3 Multi-center Study of Evaluate the Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma
Amgen Inc.0 个研究点目标入组 332 人开始时间: 2018年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 332
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
- •studyspecific
- •activities/procedures OR subject's legally acceptable
- •representative has provided informed consent prior to any study-specific
- •activities/procedures being initiated when the subject has any kind of
- •condition that, in the opinion of the investigator, may compromise the
- •ability of the subject to give written informed consent.
- •2. Age = 18 at the time of informed consent
- •3. Biopsy proven aggressive B-NHL, including DLBCL NOS, follicular
- •lymphoma Grade 3B, Primary Mediastinal B-Cell Lymphoma, T-cell rich
- •B-cell lymphoma, or DLBCL that represents transformation of indolent
- •NHL, (including follicular, marginal zone, and lymphoplasmacytoid
- •lymphoma) excluding chronic lymphocytic leukemia or Hodgkin
- •Lymphoma. Subjects with prior indolent lymphoma must have received
- •therapy after a diagnosis of transformation that is appropriate for
- •aggressive histology as described in 4. The following histologies are not
- •Lymphoblastic lymphoma
- •Burkitt lymphoma
- •Mantle cell lymphoma
- •Any histologies not specifically mentioned must be discussed with the
- •medical monitor. For subjects enrolled in the phase 3 portion of study,
- •pathologic samples will be submitted for central confirmation of disease
- •4. Refractory (no prior CMR) or relapsed (prior CMR) following front line
- •treatment of standard multiagent chemotherapy containing an
- •anthracycline AND an approved anti-CD20 agent. Examples of
- •appropriate therapy include but are not limited to R-CHOP (14 or 21), RCHOEP,
- •and DA-R-EOCH. For subjects with refractory disease and who
- •have received radiotherapy, PET positivity should be demonstrated no
- •less than 6 weeks after the last dose of radiotherapy
- •5. Biopsy-proven confirmation of relapsed disease. For subjects with de
- •novo aggressive B-cell lymphoma and primary refractory disease (ie
- •never achieving CMR), biopsy of persistent disease is preferred but
- •persistent PET positivity (ie Deauville = 4) is acceptable at a minimum.
- •For all subjects that have received radiotherapy for DLBCL, PET should
- •be performed no less than 42 days (6 weeks) after the last dose of
- •radiotherapy. For subjects with transformed disease that has been
- •characterized as refractory, rebiopsy (core or excisional biopsy) with
- •demonstration of persistent aggressive B-NHL is required
- •6. Received a minimum of 2 cycles of standard of care platinum-based
- •chemotherapy in the S1 setting and had a response of PMD, NMR, PMR as
- •centrally assessed by PET-CT scan or received at least 1 cycle of S1
- •chemotherapy and had evidence of PD as centrally assessed. A presalvage
- •scan is required to be submitted to the central reader if a
- •subject had only 1 cycle of pre-salvage chemotherapy.
- •7. Radiographically measurable disease with a clearly demarcated nodal
- •lesion at least 1.5 cm in its largest dimension or a target extranodal
- •lesion at least 1.0 cm in its largest dimension
- •8. Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •9. Intention to proceed to HDT and autologous HSCT per institutional
- •10. Laboratory parameters (completed within 14 days prior to
- •enrollment and after the last cycle of S1 chemotherapy):
- 另有 7 项未显示
排除标准
- •1. CMR following S1 chemotherapy
- •2. Treatment within 30 days prior to randomization with another investigational device or drug study (ies). Other investigational procedures while participating in this study are excluded
- •3. Prior anti-CD19-directed therapies
- •4. Prior HDT with autologous HSCT
- •5. Prior allogeneic HSCT
- •6. Presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis
- •7. Evidence of CNS involvement by NHL
- •8. Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti-hepatitis C virus positive)
- •9. History of malignancy other than B-NHL within the past 3 years with the exception of:
- •Malignancy treated with curative intent and with no known active disease present for = 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Adequately treated breast ductal carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- •10. Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
- •11. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge.
- •12. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •13. Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed while receiving blinatumomab and for an additional 48 hours after the last dose of blinatumomab. (Females of child bearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test.)
- •14. Female subjects of childbearing potential unwilling to use an effective method of contraception while receiving blinatumomab and for an additional 48 hours after the last dose of blinatumomab.
- •Note: The pregnancy, breastfeeding and contraceptive requirements are specific for blinatumomab. The investigator is responsible for providing the subject (male and female) with pregnancy and breastfeeding (female only) avoidance requirements for other medications given during the study.
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