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    Summary
    EudraCT Number:2016-004339-19
    Sponsor's Protocol Code Number:UTX-TGR-204
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-01-25
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-004339-19
    A.3Full title of the trial
    A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination with Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination with Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
    A.4.1Sponsor's protocol code numberUTX-TGR-204
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02656303
    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 SponsorTG Therapeutics
    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 supportTG Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBrillance Sp. z o.o.
    B.5.2Functional name of contact pointIzabela Kozdraś
    B.5.3 Address:
    B.5.3.1Street AddressKrólowej Jadwigi 167 b
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code30-212
    B.5.3.4CountryPoland
    B.5.4Telephone number+48668166876
    B.5.5Fax number+48327390088
    B.5.6E-mailikozdras@brillance.pl
    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/3/09/699
    D.3 Description of the IMP
    D.3.1Product nameUblituximab
    D.3.2Product code TG-1101
    D.3.4Pharmaceutical form Concentrate 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 INNUBLITUXIMAB
    D.3.9.1CAS number 1174014-05-1
    D.3.9.2Current sponsor codeTG-1101
    D.3.9.3Other descriptive nameLFB-R603, TGTX1101
    D.3.9.4EV Substance CodeSUB182428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameUmbralisib
    D.3.2Product code TGR-1202
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUmbralisib
    D.3.9.2Current sponsor codeTGR-1202
    D.3.9.3Other descriptive nameRP-5307 (pTSA Salt), RP-5264 (free base)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Chronic Lymphocytic Leukemia
    E.1.1.1Medical condition in easily understood language
    CLL is a type of cancer that starts from cells that become certain white blood cells (called lymphocytes) in the bone marrow. The cancer cells start in the bone marrow but then go into the blood.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    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
    For subjects previously on Arms B, C, & D of Study UTX-TGR-304:
    To observe the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR)

    For subjects previously on Arm A of Study UTX-TGR-304:
    To evaluate the progression-free survival (PFS) and duration of response
    (DOR)
    E.2.2Secondary objectives of the trial
    For subjects previously on Arms B, C, & D of Study UTX-TGR-304:
    • To observe the progression-free survival (PFS) and duration of
    response (OR)
    • To observe the % of subjects that achieve MRD negativity
    • To observe the safety of ublituximab in combination with TGR-1202

    For subjects previously on Arm A of Study UTX-TGR-304:
    To evaluate the safety of Ublituximab in combination with TGR-1202
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Prior treatment in clinical trial UTX-TGR-304
    a.Confirmed progression by IRC from Arms B, C, or D after at least two
    cycles of treatment in trial UTX-TGR-304. There is no required timeframe
    to begin treatment on the UTX-TGR-204 protocol; however, if other
    therapies to treat the disease are implemented in the interim, the
    subject will not be eligible to enroll in the study.
    b.Non-progressing subjects from Arm A may be eligible for enrollment
    when protocol UTX-TGR-304 is completed
    2.Adequate organ system function, defined as follows:
    a.Absolute neutrophil count (ANC) > 750 x 103/mm3 (0.75 K/μL) mL of
    blood / platelet count > 40 x 103/mm3 (40 K/μL) mL of blood unless
    cytopenias are related to bone marrow involvement.
    b.Total bilirubin ≤1.5 times the upper limit of normal (ULN) with the
    exception of Gilbert's Disease and Autoimmune Hemolytic Anemia.
    c.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
    ≤2.5 x ULN if no liver involvement or ≤5 x the ULN if known liver
    involvement
    d.Calculated creatinine clearance >30 mL/min (as calculated by the
    Modified Cockcroft-Gault formula (using ideal body mass [IBM]).
    3.ECOG performance status ≤ 2
    4.Ability to swallow and retain oral medication
    5.Willingness and ability to comply with trial and follow-up procedures,
    give written informed consent
    E.4Principal exclusion criteria
    1.Prior treatment with obinutuzumab + chlorambucil (Arm B subjects) or
    ublituximab (Arm C subjects) within 7 days of Cycle 1/Day 1.
    2.Subjects refractory to (progressing on) UTX-TGR-304 Treatment Arm A
    (ublituximab + TGR-1202).
    3.Known histological transformation from CLL to an aggressive
    lymphoma (i.e. Richter's transformation).
    4.Evidence of chronic active Hepatitis B defined as Hepatitis B surface
    antigen positive or Hepatitis B DNA positive by PCR (HBV, NOT including
    subjects with prior hepatitis B vaccination who are Hepatitis B surface
    antibody positive only;) or chronic active Hepatitis C infection (HCV)
    defined as Hepatitis C RNA positive by PCR, cytomegalovirus (CMV) DNA
    positive by PCR, or known history of HIV. If HBc antibody, HCV antibody
    or CMV IgG and/or IgM antibody is positive the subject must be
    evaluated for the presence of HBV, HCV, or CMV by PCR - See Appendix
    D.
    5.Evidence of ongoing systemic bacterial, fungal or viral infection, except
    localized fungal infections of skin or nails. NOTE: Subjects may be
    receiving prophylactic antiviral or antibacterial therapies at investigator
    discretion. Use of anti-pneumocystis pneumonia prophylaxis is required
    prior to Cycle 1/Day 1 and for the first 2 cycles. After cycle 2, is per
    investigator discretion.
    6.Woman who are pregnant or lactating.
    7.Live virus vaccines four (4) weeks prior to or during ublituximab
    therapy.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR)
    ORR is defined as sum of CR and PR rates.
    Complete Response (CR) Rate
    CR rate is defined as the proportion of subjects who achieve a CR.
    Progression-free survival (PFS)
    PFS is defined as the interval from enrollment to the earlier of the first
    documentation of definitive disease progression or death from any
    cause.
    Definitive disease progression based on standard criteria (Hallek et al.
    2008) and occurring for any reason (i.e., increasing lymphadenopathy,
    organomegaly or bone marrow involvement; decreasing platelet count,
    hemoglobin, or neutrophil count; or worsening of disease-related
    symptoms) other than lymphocytosis.
    Minimal Residual Disease (MRD) Negativity Rate
    MRD negativity rate is defined as the proportion of subjects who are
    MRD negative.
    Duration of response (DOR)
    DOR is defined as the interval from the first documentation of CR or PR
    to the earlier of the first documentation of definitive disease progression
    or death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the study period, all subjects will be evaluated for response by CT
    and/or MRI. Evaluations are to be obtained at approximately cycles 3, 6
    and 12. Following cycle 12, evaluations should occur at least every 12
    cycles unless clinically indicated more frequently. The determination of
    response and progression will be based on IWCLL criteria (Hallek M,
    2008) by the treating investigator
    E.5.2Secondary end point(s)
    For subjects previously on Arms B, C, & D of Study UTX-TGR-304:
    Progression-free survival (PFS)
    PFS is defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression or death from any
    cause.
    Definitive disease progression based on standard criteria (Hallek et al. 2008) and occurring for any reason (i.e., increasing lymphadenopathy,
    organomegaly or bone marrow involvement; decreasing platelet count, hemoglobin, or neutrophil count; or worsening of disease-related
    symptoms) other than lymphocytosis.
    Duration of response (DOR)
    DOR is defined as the interval from the first documentation of CR or PR
    to the earlier of the first documentation of definitive disease progression
    or death from any cause.
    Minimal Residual Disease (MRD) Negativity Rate
    MRD negativity rate is defined as the proportion of patients who are MRD
    negative.
    For subjects previously on Arm A of Study UTX-TGR-304:
    Safety
    All Adverse Events (AE's) will be reported and evaluated using National
    Cancer Institute's Common Terminology Criteria (CTCAE) v4.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the study period, all subjects will be evaluated for response by CT
    and/or MRI. Evaluations are to be obtained at approximately cycles 3, 6
    and 12. Following cycle 12, evaluations should occur at least every 12
    cycles unless clinically indicated more frequently. The determination of
    response and progression will be based on IWCLL criteria (Hallek M,
    2008) by the treating investigator
    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) 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Italy
    Poland
    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
    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 months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 500
    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 can remain on study drugs until removed for progression or removed per investigator discretion – Sponsor will continue to provide drug for the patient
    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 Decision2017-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-07-11
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