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    Summary
    EudraCT Number:2014-003418-10
    Sponsor's Protocol Code Number:IRST202.02
    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:2014-09-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003418-10
    A.3Full title of the trial
    PEPTIDE RECEPTOR RADIONUCLIDE THERAPY WITH 90Y-DOTATOC IN RELAPSED/REFRACTORY DIFFUSE LARGE B CELL AND MANTLE CELL LYMPHOMAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PEPTIDE RECEPTOR RADIONUCLIDE THERAPY WITH 90Y-DOTATOC IN RELAPSED/REFRACTORY DIFFUSE LARGE B CELL AND MANTLE CELL LYMPHOMAS
    A.4.1Sponsor's protocol code numberIRST202.02
    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 SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS
    B.1.3.4CountryItaly
    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 supportIRST IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRST IRCCS
    B.5.2Functional name of contact pointCentro di Coordinamento Studi IRST
    B.5.3 Address:
    B.5.3.1Street AddressDipartimento di Oncologia ed Ematologia, Ospedale Civile S. Maria delle Croci, viale Randi, 5
    B.5.3.2Town/ cityRavenna
    B.5.3.3Post code47014
    B.5.3.4CountryItaly
    B.5.4Telephone number+390544285813
    B.5.5Fax number+390544285330
    B.5.6E-mailcc.ubsc@irst.emr.it
    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 name[90Y–DOTA0-Tyr3]-Octreotide (90Y-DOTATOC)
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 NA
    D.3.9.2Current sponsor code90Y-DOTATOC_IRSTIRCCS
    D.3.9.3Other descriptive name90Y-DOTATOC_IRSTIRCCS
    D.3.9.4EV Substance CodeSUB167934
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.8 to 2.8
    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 Yes
    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
    Relapsed or refractory DLBCL (DIFFUSE LARGE B CELL LYMPHOMAS) or MCL (MANTLE CELL LYMPHOMAS)
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory DLBCL (DIFFUSE LARGE B CELL LYMPHOMAS) or MCL (MANTLE CELL LYMPHOMAS)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 the overall response rate of Y-PRRT in relapsed or refractory DLBC and MCL NHL, not suitable to other therapies, included HDCT (high dose chemotherapy), or patients relapsed after HDCT with ASCT (Autologous stem cell transplant).
    E.2.2Secondary objectives of the trial
    The secondary objectives are acute and late toxicity, the type and duration of lymphocyte toxicity, (B, T, NK lymphocytes), progression free survival, overall survival and Quality of Life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or Female, aged >18 years.
    2 . Histologically confirmed relapsed or refractory DLBCL or MCL not suitable to other treatments.
    3. Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT with 68Ga-DOTATOC images demonstrate a significant uptake in the tumour (SSR-positive tumour).
    4. Patients must have at least one bidimensional measurable lesion with long axis > 15 mm at CT scan (MRI is allowed only if CT scan cannot be performed), according to Cheson Criteria [48].
    5. ECOG performance status ≤ 2.
    6. Life expectancy of at least 3 months.
    7. Adequate cardiac function (EF >50%) as assessed at echocardiography and ECG.
    8. Conserved hematological, liver and renal parameters, and in particular: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin ≤1.5 X UNL (upper normal limit), ALT <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL
    9. Patients must not have received other treatments with radiopeptides (e.g. 111In-pentetreotide, 177Lu-DOTATATE, 131I-MIBG).
    10. If female of childbearing potential, agreement to use adequate contraceptive
    methods (e.g., oral contraceptives, condoms, or other adequate barrier
    controls, intrauterine contraceptive devices, or sterilization) beginning at
    screening visit and continuing until 3 months following last treatment with study
    drug. Negative serum pregnancy test for females of childbearing potential within 7
    days of starting treatment.
    E.4Principal exclusion criteria
    1. Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).
    2. Bone marrow invasion > 25 %.
    3. Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers); subjects must be
    free from other neoplasms at least 3 years.
    All acute toxic effects of any prior therapy (including surgery radiation therapy,chemotherapy) must have resolved
    to a grade <= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version
    4.0 (CTCAE).
    4. Evidence of myelodysplastic syndrome or other hematologic diseases
    5. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks.
    6. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
    7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive
    heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit
    compliance with study requirements.
    8. Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HbsAg). In addition,
    if negative for HBsAg but Hepatits B core antibody (HBcAb) positive (regardless of HBsAb status), a HBV DNA test
    will be performed and if positive the subject will be excluded.
    Any patient with HBcAb positivity will receive anti viral prophylaxis during the study, according to the procedures
    suggested by local Hepatology service.
    9. History of allergic reactions attributed to compounds of similar chemical or biologic composition.
    10. Previous autologous stem cell transplant in the last 2 months.
    E.5 End points
    E.5.1Primary end point(s)
    overall response rate of Y-PRRT in relapsed or refractory DLBC and MCL NHL, not suitable to other therapies, included HDCT (high dose chemotherapy), or patients relapsed after HDCT with ASCT (Autologous stem cell transplant).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    E.5.2Secondary end point(s)
    Acute and late toxicity, the type and duration of lymphocyte toxicity, (B, T, NK lymphocytes), progression free survival, overall survival and Quality of Life
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-48 months
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state35
    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)
    Evaluation after 3, 6, 12, 18, 24, 36, 48 months from the last cycle of therapy: physical examination, emathological exams, urinalysis, lymphocyte subpopulation count (at months 3 and 6 only), EORTC QLQ-C30 Questionnaire.
    CT scan with contrast after 1, 12, 24, 36, 48 months from the EoT (end of treatment)); PET/TC total-body with 18F-FDG after 1, 6, 18 months after the EoT for 2 years and every year until the end of the study; Chest X-ray and abdomen ultrasound 30, 42 months after the EoT.
    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 Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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