EUCTR2009-016378-34-BE进行中（未招募）1 期
An Open Label, Phase 1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 193
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)Men or women at least 18 years of age or older at time of study entry
- •2)Written informed consent obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- •3)Diagnosis
- •?Arm A: CLL (including SLL), DLBCL, or FL; SLL, DLBCL, and FL must be histologically confirmed
- •?Arm B: Histologically confirmed SLL or previous confirmation of B-cell CLL with a characteristic immunophenotype by flow cytometry
- •?Arm D: Histologically confirmed anti-CD20-refractory (defined as any subject with less than a PR to any prior anti-CD20-based therapy or progression within 6 months after completing therapy with any anti-CD20-based regimen, including maintenance rituximab) aggressive B-cell DLBCL, including FL transforming to DLBCL, transformed indolent lymphoma, MCL, or Grade 3b FL, according to the World Health Organization/American Joint Committee on Cancer criteria
- •4)Optional: Willing to provide a fresh tumor sample if a sufficient quantity of archival tumor sample is not available (Arms B and D)
- •5)Evaluable/measurable disease
- •?Non-CLL B-cell malignancies (Arms A and D):
- •?Histologically confirmed B-cell NHL (FL or DLBCL), transformed indolent lymphoma, and MCL: Measurable disease defined as = 1 lesion = 20 mm in one dimension or =15 mm in 2 dimensions as measured by conventional or high-resolution (spiral) computed tomography (CT). For Arm D: disease evaluable by the International Working Group criteria (Cheson et al, 2007)
- •?Baseline PET or PET/CT scans must show positive lesions compatible with CT-defined anatomical tumor sites (only applicable for FL, DLBCL, MCL, transformed indolent lymphoma, and FL transforming to DLBCL)
- •?CLL (Arms A and B):
- •?Confirmed B-cell CLL/SLL with a characteristic immunophenotype by flow cytometry, and symptomatic disease requiring treatment
- •?CT scans showing involvement of = 1clearly demarcated lesions measuring = 1.5 cm
- •6)Prior therapy
- •?Histologically confirmed B-cell NHL (FL or DLBCL): Relapsed from or refractory to = 1 prior regimen containing rituximab, either alone or in combination, and not be a candidate for hematopoietic SCT or BM transplant
- •?B-cell CLL: Relapsed from or refractory to = 2 prior lines of treatment, = 1 of which must have contained rituximab
- •?Arm B: Relapsed from or refractory to = 2 prior chemotherapy regimens with = 1 regimen containing rituximab
- •?Arm D: Refractory to = 1 regimen containing any anti-CD20-based therapy, including salvage regimens and maintenance rituximab. Refractory subjects are defined as any subject with less than a PR to any prior anti-CD20-based therapies or progressed within 6 months after completing therapy with any anti-CD20-based regimens, including maintenance rituximab. These subjects must not be eligible for hematopoietic SCT or BM transplant
- •7)Prior radiation therapy is allowed provided exposure does not exceed an area of 25% of marrow space and occurred = 6 weeks prior to the first dose of MEDI-551 (Arm A only)
- •8)Karnofsky Performance Status = 70
- •9)Life expectancy of = 12 weeks
- •10)Adequate hem
排除标准
- •1)Any available standard line of therapy known to be life-prolonging or life-saving
- •2)Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
- •3)History of allergy or reaction to any component of the MEDI-551 formulation
- •4)Receipt of any chemotherapy or small molecule targeted therapy (such as imatinib or other tyrosine kinase inhibitors, and including any experimental therapies) or radiation therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of MEDI-551
- •5)Receipt of any biological or immunological-based therapies (including experimental therapies) for leukemia, lymphoma, or myeloma (including, but not limited to, MAb therapy such as rituximab, or cancer vaccine therapies) within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of MEDI-551
- •6)Previous therapy directed against CD19, such as MAbs or MAb conjugates
- •7)Live or attenuated vaccines (other than experimental cancer vaccine therapy) within 28 days prior to receiving the first dose of MEDI-551
- •8)Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic, or antiviral therapy or for which other supportive care is given
- •9)Autologous SCT within 12 weeks prior to study entry (Arms A and D only)
- •10)Prior allogeneic SCT or organ transplant (Arms A and D only)
- •11)Human immunodeficiency virus (HIV) positive serology or AIDS
- •12)Active hepatitis B as defined by seropositivity for hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody. Subjects with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases
- •13)Ongoing = Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria. Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551
- •14)Use of systemic steroids within 7 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted). Subjects may take replacement doses of steroids (defined as = 30 mg/day hydrocortisone or the equivalent) if on a stable dose for at least 2 weeks prior to the first dose of MEDI-551
- •15)Documented current central nervous system involvement by leukemia or lymphoma
- •16)Pregnancy or lactation
- •17)Previous medical history, or evidence, of an intercurrent illness that at the discretion of the principal investigator may compromise the safety of the subject in the study
- •18)Clinically significant abnormality on electrocardiogram (ECG). The corrected QT interval (QTc, Fridericia) must be < 470 milliseconds for men and < 490 milliseconds for women (Must be confirmed by at least 2 additional 12-lead ECGs at least 2 minutes apart such that average manually over-read QTcF based on 3 ECGs exceeds stated thresholds)
- •19)Any physical, social, or psychiatric condition that would prevent effective cooperation or participation in the study
- •20)Concurrent enrollment in another clinical study, unless in a follow-up period or it is an observational study
- •21)Employees of the clinical study site who are directly
研究者
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