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    Summary
    EudraCT Number:2015-001814-85
    Sponsor's Protocol Code Number:PNT2258-04-Richter's
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-001814-85
    A.3Full title of the trial
    A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brighton: PNT2258 for Treatment of Patients with Richter's Transformation
    A.3.2Name or abbreviated title of the trial where available
    Brighton
    A.4.1Sponsor's protocol code numberPNT2258-04-Richter's
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02378038
    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 SponsorProNAi Therapeutics, Inc.
    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 supportProNAi Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProNAi Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address46701 Commerce Center Drive
    B.5.3.2Town/ cityPlymouth Michigan
    B.5.3.3Post code48170
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1514653-7631
    B.5.6E-mailvratheau@pronai.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1542
    D.3 Description of the IMP
    D.3.2Product code PNT2258
    D.3.4Pharmaceutical form Dispersion 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 INNrosomidnar
    D.3.9.1CAS number 1443989-00-1
    D.3.9.2Current sponsor codePNT100
    D.3.9.4EV Substance CodeSUB179722
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 non-Hodgkin's lymphoma with Richter's Transformation (RT) from chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
    E.1.1.1Medical condition in easily understood language
    Richter’s Transformation
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10058728
    E.1.2Term Richter's syndrome
    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
    To assess overall response rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR) according to the revised 2014 International Working Group (IWG) criteria based upon blinded independent review.
    E.2.2Secondary objectives of the trial
    ∙ To assess disease control rate (DCR), duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS) and overall survival rate at 6 and 12 months.
    ∙ To determine the number of patients who receive stem cell transplant (SCT) after treatment with PNT2258.
    ∙ Analyses of biomarkers in order to identify possible predictors of outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent
    2) ≥18 years of age
    3) Histologically confirmed diagnosis of diffuse large B-cell lymphoma in the setting of Richter's Transformation (RT) from chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
    4) Availability of fresh or archived tumor tissue
    5) FDG PET-CT disease-positive baseline scan
    6) ECOG performance status of 0-1
    7) Evidence of disease progression at study entry
    8) Discontinuation of prior anticancer therapy for ≥7 days and recovery to ≤ CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy
    9) Previously received at least one prior regimen for CLL
    10) Adequate organ function
    11) Adequate bone marrow function
    12) Normal coagulation profile
    13) Ability to participate in the clinical study for at least 2 cycles (6 weeks)
    E.4Principal exclusion criteria
    1) Concurrent non-hematologic malignancies requiring treatment
    2) More than 1 prior regimen for DLBCL
    3) Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma (i.e., discovery of CLL and another lymphoma at time of original diagnosis), interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation
    4) Ongoing risk of bleeding due to active peptic ulcer disease or known bleeding diathesis or requirement for systemic therapeutic levels of anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions or oral anticoagulants
    5) Central nervous system (CNS) or leptomeningeal involvement of lymphoma
    6) Concurrent clinically significant illness or medical condition that could adversely affect subject safety or the integrity of study results, as determined by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is a binary variable determined for each patient indicating whether or not his or her disease has responded to PNT2258 (as indicated by CR, PR) at any time during treatment using centrally read imaging evaluated using the Lugano Classification (i.e., FDG PET-CT-based response).
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 weeks and 15 weeks after baseline
    E.5.2Secondary end point(s)
    24 week disease control determined for each patient as a binary variable indicating whether or not they have stable disease or better
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after baseline
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 EEA36
    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
    France
    Hungary
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Patients will continue to receive treatment until they experience disease progression, intolerable toxicity, request for voluntary withdrawal or if, in the opinion of the investigative physician, the patient is no longer benefiting from exposure to PNT2258. All patients will be followed until disease progression, withdrawal criterion is met, death, or lost to follow-up.
    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 months0
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 49
    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)
    Patients will be monitored for adverse events for 30 days after the last dose of study therapy.
    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 Decision2015-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-07
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