EUCTR2009-016378-34-FR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
- 136
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
- •1) Men or women at least 18 years of age or older at time of study entry;
- •2) Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations;
- •3) Histologically confirmed CLL (including SLL), DLBCL, FL, or MM;
- •4) Subjects with histologically-confirmed B-cell NHL (FL or DLBCL) must:
- •Be relapsed or refractory after at least one prior regimen containing rituximab, either alone or in combination;
- •Have measurable disease (at least one lesion = 20 mm in one dimension or =15 mm in two dimensions as measured by conventional or high resolution [spiral] computed tomography (CT);
- •Not be candidates for hematopoietic stem cell (HSC) or bone marrow (BM) transplant;
- •5) For B-cell CLL subjects, the following criteria are required for eligibility:
- •Previous confirmation of B-cell CLL with a characteristic immunophenotype by flow cytometry;
- •Be relapsed or refractory after at least 2 prior lines of treatment, at least one of which must have contained rituximab and not be a candidate for hematopoietic stem cell (HSC) or bone marrow (BM) transplant;
- •Have symptomatic disease that requires treatment;
- •6) For subjects with MM, the following criteria are required:
- •Be relapsed or refractory after at least one prior line of therapy;
- •Not be a candidate for HSC or BM transplant;
- •Indication for active treatment as follows:
- •Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or documented clonal plasmacytoma;
- •Plus one or more of the following:
- •Calcium elevation (> 11.5 mg/dL);
- •Renal insufficiency (creatinine > 2.0 mg/dL);
- •Anemia (hemoglobin < 10 g/dL);
- •Bone disease (lytic bone lesions by X-ray or CT scan or osteopenia considered secondary to MM);
- •7) Karnofsky Performance Status = 70;
- •8) Life expectancy of = 12 weeks;
- •9) Prior radiation therapy is allowed provided exposure does not exceed an area of 25% of marrow space;
- •10) Adequate hematological function defined as:
- •Hemoglobin = 9 g/dL;
- •Absolute neutrophil count = 1500/mm3;
- •Platelet count = 75,000/mm3 (except for CLL subjects with evidence of bone marrow disease, who must have a platelet count = 50,000/mm3);;
- •11) Adequate organ function defined as follows:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2 × institutional upper limit of normal (ULN);
- •Bilirubin = 1.5 × ULN except in the case of subjects with documented Gilbert’s disease, = 2.5 × ULN;
- •Serum creatinine < ULN or for MM only, < 5 × ULN;
- •12) Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use adequate contraception from screening through 90 days after the last dose of MEDI-551. An acceptable method of contraception is defined as one that has no higher than a 1% failure rat. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through 90 days after the last dose of MEDI-551;
- •Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses). S
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) regimens within 6 weeks 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, monoclonal antibody therapy such as rituximab, or cancer vaccine therapies) within 6 weeks prior to the first dose of MEDI-551 (This time period is approximately 2 terminal elimination half-lives of rituximab, and represents a reasonable time for subjects with progressing disease to wait for therapy).
- •6) Previous therapy directed against CD19, such as monoclonal antibodies or monoclonal antibody conjugates;
- •7) Vaccination (other than experimental cancer vaccine therapy) within 28 days prio to receiving the first dose of MEDI-551;
- •8) History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured;
- •9) Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic, or antiviral therapy or for which other supportive care is given;
- •10) Autologous stem cell transplantation within 12 weeks prior to study entry;
- •11) Allogeneic stem cell transplantation or any other organ transplant;
- •12) HIV positive serology or AIDS;
- •13) Active hepatitis B or C infection as defined by seropositivity for hepatitis B (HBsAg) or hepatitis C antibody, and elevated liver transaminases;
- •14) Ongoing = Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria. For subjects with MM, serum calcium must be < Grade 4 (< 13.5 mg/dL) and serum creatinine must be < 5 × ULN;
- •15) Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551;
- •16) 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;
- •17) Documented current central nervous system involvement by leukemia or lymphoma;
- •18) Pregnancy or lactation;
- •19) 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;
- •20) Clinically significant abnormality on ECG. The QTc (Fridericia) for men must be < 470 msec, and for women < 490 msec;
- •21) Any physical, social, or psychiatric condition that would prevent effective cooperation or participation in the study;
- •22) Concurrent enrollment in another clinical study;
- •23) Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
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