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    Summary
    EudraCT Number:2009-016378-34
    Sponsor's Protocol Code Number:MI-CP204
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-20
    Trial 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 ConcernedBelgium - FPS Health-DGM
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MEDI-551 in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
    A.4.1Sponsor's protocol code numberMI-CP204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00983619
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Addressn/a
    B.5.3.2Town/ cityn/a
    B.5.3.3Post coden/a
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialtransparency@astrazeneca.com
    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 No
    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 1299440-37-1
    D.3.9.2Current sponsor codeMEDI-551
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    Relapsed or refractory advanced B-cell malignancies:
    chronic lymphocytic leukemia (CLL),
    small lymphocytic lymphoma (SLL), B-cell non-Hodgkin’s lymphoma (NHL) (subtypes: follicular lymphoma (FL), diffuse large B-cell lymphoma(DLBCL), mantle cell lymphoma, and anti-CD20-refractory aggressive lymphomas)
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory advanced B-cell malignancies
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 in Arm A 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.
    The primary objective of Arm B is to determine the MTD or highest protocol-defined dose of MEDI-551 in the absence of exceeding the MTD in subjects with relapsed or rituximab-refractory CLL (defined as those with less than a PR or progression within 6 months after completing therapy with rituximab), to evaluate further the safety and tolerability of MEDI-551 at the dose selected in the dose-escalation phase in subjects with relapsed or rituximab-refractory CLL, and to evaluate the clinical activity of MEDI-551 at the dose selected in the dose-escalation phase in subjects with relapsed or rituximab-refractory CLL.
    The primary objective of Arm D is to evaluate the clinical activity of MEDI-551 in subjects with any anti-CD20-refractory aggressive lymphomas.
    E.2.2Secondary objectives of the trial
    Arm A
    1)To determine the preliminary efficacy profile of MEDI-551 in subjects with advanced B cell malignancies (CLL, DLBCL, and FL)
    2)To determine the 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 Ig levels, including time to recovery after treatment
    4.)To determine the IM of MEDI-551 in subjects with advanced B-cell malignancies
    Arm B
    1)To evaluate the PK and IM of MEDI-551 at doses studied in subjects with relapsed or rituximab-refractory CLL
    2)To evaluate the effect of therapy on the B-lymphocyte level in peripheral blood, including time to recovery of B-lymphocyte level
    Arm D
    1.)To determine the safety and tolerability of MEDI-551 in subjects with any anti-CD20-refractory aggressive lymphomas
    2)To evaluate the PK and IM of MEDI-551
    3)To evaluate the effect of therapy on the B-lymphocyte level in peripheral blood, including time to recovery of B-lymphocyte level
    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 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
    ◦Arm A:
    ▪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 hematologic function
    ◦Arm A (except for CLL subjects with significant BM involvement by biopsy):
    ▪Hemoglobin ≥ 9 g/dL, (≥ 8 g/dL for subjects who are transfusion dependent)
    ▪Absolute neutrophil count ≥ 1500/mm3
    ▪Platelet count ≥ 75,000/mm3
    ◦Arms B and D must meet the following criteria:
    ▪Hemoglobin ≥ 8 g/dL
    ▪Absolute neutrophil count ≥ 1000/mm3
    ▪Platelet count ≥ 75,000/mm3
    ▪In the event of significant BM involvement, the above hematologic criteria will not be required for enrollment eligibility
    11)Adequate organ function defined as follows:
    ◦AST and ALT ≤ 2 × institutional ULN
    ◦Bilirubin ≤ 1.5 × ULN except in the case of subjects with documented Gilbert’s disease, ≤ 2.5 × ULN
    ◦Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 60 mL/min as determined by the Cockcroft-Gault equation
    12)Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from screening and must agree to continue using such precautions for at least 180 days after the last dose of investigational product. A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly.
    13)Non-sterilized males who are sexually active with a female of childbearing potential must use a highly effective method of contraception from at least Day 1 through 90 days after the last dose of investigational product
    14)Negative serum beta human chorionic gonadotropin (βhCG) test (for women of childbearing potential only)
    15)Females or female partners not of childbearing potential must have been surgically sterilized or postmenopausal (as defined above in inclusion criterion #12). Sterilized males must be at least 1 year post vasectomy
    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) 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 involved with the conduct of the study, or immediate family members of such individuals. These subjects may be treated at another site participating in the study
    E.5 End points
    E.5.1Primary end point(s)
    Arm A:
    1) MTD or OBD: DLTs
    2) Safety: AEs, SAEs, laboratory evaluations, vital signs, physical examinations, and ECGs
    Arm B:
    1) MTD is defined as the highest dose where ≤ 1 out of 6 subjects experience a DLT during the DLT evaluation period or the highest protocol-specified dose not exceeding MTD: DLTs
    2) Safety: AEs, SAEs, laboratory evaluations, vital signs, physical examinations, and ECGs
    3) Clinical activity/efficacy: CR, duration of CR, PR, objective response, disease control, TTR, duration of objective response, duration of disease control, PFS, and OS
    Arm D:
    1) Clinical activity/efficacy: CR, duration of CR, PR, objective response, disease control, TTR, duration of objective response, duration of disease control, PFS, and OS
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) MTD or OBD determination: Approximately 16 months from the start of each arm
    2) Preliminary safety profile of MEDI-551: Approximately 120 months from the start of each arm
    3) Clinical activity/efficacy: Approximately 16 months from the start of Arms B and D.
    E.5.2Secondary end point(s)
    Arm A:
    1) Clinical activity/efficacy: CR, duration of CR, PR, objective response, disease control, TTR, duration of objective response, duration of disease control, PFS, and OS
    2) Effect of MEDI-551 on circulating lymphocyte populations: circulating levels of blood mononuclear cells, including T-cells, B-cells, NK cells and monocytes
    3) Pharmacokinetics: PK profiles and parameters, including maximum observed concentration (Cmax), AUC, clearance (CL), and t½, of MEDI-551
    4) Incidence of anti-MEDI-551 antibodies based on samples obtained from each subject at multiple timepoints before and after dosing
    Arm B:
    1) Pharmacokinetics: PK profiles and parameters, including Cmax, AUC, CL, and t½, of MEDI-551
    2) Incidence of anti-MEDI-551 antibodies based on samples obtained from each subject at multiple timepoints before and after dosing
    3) Effect of MEDI-551 on B-lymphocyte levels in peripheral blood, including time to recovery of B-lymphocyte level
    Arm D:
    1) Safety: AEs, SAEs, laboratory evaluations, vital signs, physical examinations, and ECGs
    2) Pharmacokinetics: PK profiles and parameters, including Cmax, AUC, CL, and t½, of MEDI-551
    3) Incidence of anti-MEDI-551 antibodies based on samples obtained from each subject at multiple timepoints before and after dosing
    4) Effect of MEDI-551 on B-lymphocyte levels in peripheral blood, including time to recovery of B-lymphocyte level
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 120 months to evaluate all secondary endpoints from the start of each arm.
    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 EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Spain
    United States
    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 years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    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.1.2.1Number of subjects for this age range: 77
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legal representative may provide consent on behalf of subject if applicable
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 193
    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 Decision2010-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-06
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