EUCTR2016-003255-30-BE进行中（未招募）1 期
A Phase 2 Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects With High-risk Diffuse Large B-Cell Lymphoma Post-autologous Hematopoietic Stem-cell Transplantation
Amgen Inc.0 个研究点目标入组 90 人开始时间: 2018年2月27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
- 90
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
- •- Age = 18 at time of informed consent
- •- Biopsy-proven DLBCL excluding DLBCL that represents transformation of indolent NHL (Lymphoblastic Lymphoma and Burkitt Lymphoma histology are not eligible)
- •- Subject has = 1 characteristic feature of high-risk DLBCL:
- •High-risk first complete remission (defined as interim PET-CT positive or < complete remission to frontline chemotherapy AND achieved complete remission to platinum-containing salvage)
- •Relapse within 1 year of diagnosis
- •Secondary aaIPI > 1 (see Appendix D)
- •Partial response/partial metabolic response after minimum of 2 cycles of platinum-containing salvage chemotherapy
- •C-myc rearrangement
- •- aHSCT with high-dose chemotherapy following first (or later) salvage treatment.
- •- PET-CT negative (Deauville score = 3) 90 days (± 30 days) post aHSCT
- •- Available relapsed and/or diagnostic pathology formalin-fixed paraffin-embedded (FFPE) tumor block or slide samples at the time of enrollment including the successful identification of malignant clone sequences by the central laboratory.
- •- MRD plasma sample collected = 3 weeks from post aHSCT PET-CT scan
- •- MRD-positive assessment (by NGS analysis) at enrollment or at any time during the run-in 1 period
- •- PET-CT negative (defined by Deauville criteria = 3) at run-in 2 performed = 3 weeks from MRD-positive assessment at run-in 1. Historical PET-CT are allowed if performed = 6 weeks from day 1 (first dose of blinatumomab) and subject has no clinical signs or symptoms suggestive of disease progression (eg, increase in lactate dehydrogenase [LDH] not otherwise explained)
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •- Clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, and psychosis
- •- Evidence of CNS involvement with DLBCL
- •- Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
- •- Prior anti-CD19 directed therapies
- •- Prior alloHSCT
- •- Received radiation = 2 weeks prior to enrollment
- •- Infection with HIV or chronic infection with HBV or HCV
- •- History of malignancy other than DLBCL within the past 3 years with the following exceptions:
- •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
- •- Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing.
- •- 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.
- •- Women who are pregnant or breastfeeding or planning to become pregnant or breastfeed while receiving blinatumomab and for an additional 48 hours after the last treatment dose of blinatumomab. (Females of child bearing potential should only be included after a negative highly sensitive urine or serum pregnancy test.)
- •- Women of childbearing potential unwilling to use an acceptable method of effective contraception while receiving blinatumomab and for an additional 48 hours after last dose of blinatumomab.
- •- Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
- •- Subject has active infection requiring systemic therapy
- •- Any change in the part 1 eligibility criteria during the run-in period.
研究者
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