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    Summary
    EudraCT Number:2018-003889-14
    Sponsor's Protocol Code Number:NLG-LBC7
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-05-04
    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 ConcernedFinland - Fimea
    A.2EudraCT number2018-003889-14
    A.3Full title of the trial
    R-MINI-CHOP versus R-MINI-CHP in combination with polatuzumab-vedotin, as primary treatment for patients with diffuse large B-cell lymphoma, ≥80 years, or frail ≥75 years – an open label randomized Nordic Lymphoma Group phase III trial - NLG-LBC7
    Avoin satunnaistettu vaiheen III tutkimus, jossa verrataan R-MINI-CHOP-hoitoa R-MINI-CHP-hoitoon yhdessä polatutsumabi-vedotiinin kanssa ensilinjan hoitona diffuusia suurisoluista B-solulymfoomaa sairastavilla iäkkäillä potilailla (POLAR BEAR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    R-MINI-CHOP versus R-MINI-CHP in combination with polatuzumab-vedotin, as primary treatment for patients with diffuse large B-cell lymphoma, ≥80 years, or frail ≥75 years – an open label randomized Nordic Lymphoma Group phase III trial - NLG-LBC7 (POLAR BEAR)
    A.3.2Name or abbreviated title of the trial where available
    POLAR BEAR
    A.4.1Sponsor's protocol code numberNLG-LBC7
    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 SponsorSkåne University Hospital, Department of Oncology
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSkåne University Hospital, Dept. of Oncology
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRoche AB, Box 1228, 171 23 Solna
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordic Lymphoma Group, Dept. of Haematology
    B.5.2Functional name of contact pointClinical Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99, C104
    B.5.3.2Town/ city Aarhus
    B.5.3.3Post codeDK - 8200
    B.5.3.4CountryDenmark
    B.5.4Telephone number+45 7845 5855
    B.5.5Fax number+45 7846 7597
    B.5.6E-maila-cto@auh.rm.dk
    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 namepolatuzumab vedotin
    D.3.4Pharmaceutical form Powder for 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 INNPOLATUZUMAB VEDOTIN
    D.3.9.2Current sponsor codeF. Hoffman la Roche
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.8 to 1.0
    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 No
    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 Vincristine
    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 nameVincristine
    D.3.4Pharmaceutical form Solution for injection/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 INNVINCRISTINE
    D.3.9.1CAS number 57-22-7
    D.3.9.3Other descriptive nameVincristine
    D.3.9.4EV Substance CodeSUB00059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Diffuse large B-cell lymphoma.
    E.1.1.1Medical condition in easily understood language
    Diffuse large B-cell lymphoma.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10012857
    E.1.2Term Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory
    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 is to evaluate if progression-free survival with pola-R-mini-CHP is superior to that of R-mini-CHOP.
    E.2.2Secondary objectives of the trial
    To compare response duration, complete remission rate (CR), overall response rate (ORR), health-related quality of life (HRQOL), lymphoma specific survival (LSS), overall survival (OS), and safety between these regimens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥80 years or frail ≥75 years, at the discretion of the investigator
    2. Histologically confirmed (according to the WHO classification) diffuse large B-cell lymphoma stage II-IV
    3. No previous treatment for lymphoma
    4. WHO performance status 0 – 3 (Grade 3 only if related to DLBCL)
    5. Written informed consent
    E.4Principal exclusion criteria
    1. Severe cardiac disease: NYHA grade 3-4
    2. Transformation from previously diagnosed indolent lymphoma
    3. Impaired liver (transaminases > 3x normal upper limit or bilirubin > 2,0 mg/dl unless due to Gilbert´s syndrome) , renal (GFR<50ml/min) or
    other organ function not caused by lymphoma, which will interfere with the treatment.
    4. Absolute neutrophil count (ANC) <1000 cells/L or platelets <100,000 cells/L, unless due to lymphoma
    5. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and
    without relapse since 2 years, or low grade prostate cancer, not in need of treatment
    6. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
    7. Hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, doxorubicin or bendamustine, or HACA against rituximab.
    8. Peripheral neuropathy grade ≥ 2
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival:
    This is defined as the interval between randomization date and date of documented progression, first relapse, or death of any cause. 5. Otherwise, patients will be censored at the last date they were known to be alive.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously during time from randomization, treatment phase, and follow up phase (36 month after end of treatment).
    E.5.2Secondary end point(s)
    Overall survival:
    This is defined as time from registration to death of any cause. Patients still alive or lost to follow-up are censored at the last date they were known to be alive.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously during time for registration, treatment phase, and follow up phase (36 month after end of treatment).
    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 No
    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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 200
    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)
    None.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic Lymphoma Group
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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