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    Summary
    EudraCT Number:2013-001284-23
    Sponsor's Protocol Code Number:XM22-ONC-305
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001284-23
    A.3Full title of the trial
    A randomized, phase IIIB, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly patients with aggressive B cell Non-HOdgkin lymphomas at hIgh risk for R-CHOP-21-inDuced neutropenia – AVOID Neutropenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, open-label, two-arm, multicenter, comparatiVe study on efficacy and safety of lipegfilgrastim (Lonquex, TEVA) in comparison to pegfilgrastim (Neulasta®, Amgen) in elderly patients with aggressive B cell Non-HOdgkin lymphomas at hIgh risk for R-CHOP-21-inDuced neutropenia – AVOID Neutropenia
    A.3.2Name or abbreviated title of the trial where available
    AVOID Neutropenia
    A.4.1Sponsor's protocol code numberXM22-ONC-305
    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 SponsorMerckle GmbH
    B.1.3.4CountryGermany
    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 supportMerckle GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationiOMEDICO AG
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressHanferstraße 28
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number00497611524231
    B.5.5Fax number00497611524210
    B.5.6E-mailclaudia.wenig@iomedico.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 Yes
    D.2.1.1.1Trade name Lonquex
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma B.V., Computerweg 10, 3542DR Utrecht, The Netherlands
    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 nameLonquex
    D.3.2Product code XM22
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlipegfilgrastim
    D.3.9.1CAS number 1117844-87-7
    D.3.9.2Current sponsor codeXM22
    D.3.9.3Other descriptive nameGlycoPEGylated r-metHuG-CSF
    D.3.9.4EV Substance CodeSUB33778
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Neulasta®
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namepegfilgrastim
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGFILGRASTIM
    D.3.9.1CAS number 208265-92-3
    D.3.9.4EV Substance CodeSUB16451MIG
    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 No
    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
    The study population includes patients with aggressive B cell Non-Hodgkin Lymphoma (NHL) planned to receive systemic anti-cancer therapy with at least 6 cycles of R-CHOP-21, according to local standards.
    E.1.1.1Medical condition in easily understood language
    The study population includes patients with aggressive B cell Non-Hodgkin Lymphoma (NHL) planned to receive systemic anti-cancer therapy with at least 6 cycles of R-CHOP-21
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10066481
    E.1.2Term Hematological malignancy
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate non-inferiority of lipegfilgrastim (Lonquex, Teva) vs. pegfilgrastim (Neulasta®, Amgen) for the duration of severe neutropenia (DSN) in the first cycle of chemotherapy.
    E.2.2Secondary objectives of the trial
    -To compare efficacy of lipegfilgrastim and pegfilgrastim in elderly patients with B cell NHL receiving chemotherapy with R-CHOP-21 throughout the study.
    -To compare safety and tolerability of lipegfilgrastim and pegfilgrastim in elderly patients with B cell NHL receiving chemotherapy with R-CHOP-21 throughout the study.
    -To assess incidence and severity of infections throughout the study.
    -To compare effect of lipegfilgrastim and pegfilgrastim treatment on quality of life.
    -To further characterize exposure-response relationships for lipegfilgrastim.
    -To further characterize the immunogenicity of lipegfilgrastim.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Signed and dated Independent Ethics Committee (IEC)-approved written informed consent
    b. Age ≥65 years and ≤85 years
    c. Histological documentation of aggressive B cell NHL
    d. Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards
    e. ECOG score ≤2
    f. Life expectancy of at least 3 months
    g. Adequate bone marrow, renal and hepatic function as evidenced by the following within 14 days before start of chemotherapy:
    -absolute neutrophil count (ANC) ≥1.5 x 109/L
    -platelets ≥100 x 109/L
    -hemoglobin ≥9.0 g/dL
    -serum creatinine ≤1.5 x upper limit of the normal range (ULN) OR glomerular filtration rate (GFR) ≥30 mL/minute/1.73 m2
    -Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; bilirubin ≤1.5 x ULN; alkaline phosphatase limit ≤2.5 x ULN
    h. The patient is capable of understanding and complying with parameters as outlined in the protocol
    i. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD), steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
    j. The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study drug because of the possible effects on spermatogenesis). Acceptable methods of
    contraception include abstinence, female partner's use of an acceptable method of
    contraception (described above), or if female partner is surgically sterile or 2
    years post-menopausal. In addition, male patients may not donate sperm for the
    duration of the study and for 90 days after taking study drug.
    E.4Principal exclusion criteria
    a. Participation in a clinical study within 30 days before randomization
    b. Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed.
    c. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during
    the study will be withdrawn from the study.)
    d. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
    e. Active cardiac disease including any of the following:
    -Congestive heart failure >New York Heart Association (NYHA) class 2.
    -Unstable angina, new-onset angina, myocardial infarction less than 6 months before start of chemotherapy.
    -Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
    -Uncontrolled hypertension.
    f. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy.
    g. Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
    h. Patients with evidence or history of bleeding diathesis.
    i. Non-healing wound, ulcer or bone fracture.
    j. Renal failure requiring hemo- or peritoneal dialysis.
    k. Any conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
    l. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
    m. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
    n. Treatment with lithium at screening or planned during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the duration of severe neutropenia in days in the first cycle of chemotherapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    days 1, 3, 5, 8, 10, 12, 15
    E.5.2Secondary end point(s)
    - Incidence of febrile neutropenia (FN) by cycle and across all cycles
    - Incidence of severe/very severe neutropenia in Cycle 1
    - Depth of ANC nadir in Cycle 1
    - Proportion of patients with severe neutropenia lasting <1 day, <2 days, <3 days, or ≥3 days in Cycle 1
    - Time to ANC recovery in first treatment cycle
    - Incidence and severity of infections.
    - Time in hospital and time in intensive care unit due to all causes and due to FN or connected
    infections.
    - Incidence of hospitalizations by cycle due to FN.
    - Incidence of treatment with IV and oral antibiotics due to FN or connected infections.
    - Percentage of actually delivered vs. scheduled cumulative chemotherapy dose.
    - Proportion of patients with chemotherapy doses reduced, omitted, or delayed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily temperature measurement; ANC assessment days 1, 3, 5, 8, 10, 12, 15 in cycle one and days 1, 8, 15 in all other cycles
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Standard treatment
    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 Decision2014-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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