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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-016378-34
    Sponsor's Protocol Code Number:MI-CP204
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-016378-34
    A.3Full title of the trial
    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
    A.4.1Sponsor's protocol code numberMI-CP204
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedImmune, LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive name16C4-aFuc
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relasped or refractory advanced B-cell malignancies:
    chronic lymphocytic leukemia (CLL),
    multiple myeloma (MM),
    B-cell non-Hodgkin’s lymphoma (NHL) (subtypes: follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL))
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the MTD or OBD of MEDI-551 in subjects with relapsed or refractory advanced B-cell malignancies and to determine the preliminary safety profile of MEDI-551.
    E.2.2Secondary objectives of the trial
    1 To determine the preliminary efficacy profile of MEDI-551 in subjects with the following advanced B-cell malignancies:
    •CLL
    •DLBCL
    •FL
    •MM
    2 To determine the pharmacokinetics (PK) of MEDI-551 in subjects with advanced B cell malignancies.
    3 To determine the effect of treatment with MEDI-551 on circulating lymphocyte populations and immunoglobulin levels, including time to recovery after treatment.
    4 To determine the immunogenicity of MEDI-551 in these patient populations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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). Sterilized males must be at least 1-year post vasectomy;
    13) For the expansion phase only, for subjects with DLBCL or FL only, disease evaluable by the International Working Group criteria.
    E.4Principal exclusion criteria
    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.
    E.5 End points
    E.5.1Primary end point(s)
    Maximum Tolerated Dose / Optimal Biological Dose and Safety
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose Response
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Provided in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 134
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Provided in protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-06
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