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    The EU Clinical Trials Register currently displays   37981   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005069-60
    Sponsor's Protocol Code Number:P000798
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-005069-60
    A.3Full title of the trial
    R-CPOP as first line therapy for elderly patients with DLBCL and for patients with limited cardiac function with DLBCL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    R-CPOP (Rituximab plus Cyclophosphamid, Pixantron, Vincristin, Prednison) as first line therapy for elderly patients with diffuse-large B cell lymphoma (DLBCL) and for patients with limited cardiac function with DLBCL
    R-CPOP (Rituximab plus Cyclophosphamid, Pixantron, Vincristin, Prednison) als Erstlinientherapie für ältere Patienten mit diffus großzelligem B-Zell-Lymphom (DLBCL) und für Patienten mit eingeschränkter Herzfunktion mit DLBCL
    A.3.2Name or abbreviated title of the trial where available
    Pix in DLBCL first line
    A.4.1Sponsor's protocol code numberP000798
    A.5.4Other Identifiers
    Name:DRKS-NumberNumber:DRKS00000718
    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 SponsorMedical Center - University of Freiburg
    B.1.3.4CountryGermany
    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 supportServier Affaires Médicales
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Center - University of Freiburg
    B.5.2Functional name of contact pointClinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressElsaesser Str. 2
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79110
    B.5.3.4CountryGermany
    B.5.4Telephone number+49761270-73800
    B.5.5Fax number+49761270-74250
    B.5.6E-mailandrea.kunzmann@uniklinik-freiburg.de
    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 Pixuvri®
    D.2.1.1.2Name of the Marketing Authorisation holderCTI Life Sciences Limited
    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.3.4Pharmaceutical form Powder for 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 INNPixantrone
    D.3.9.1CAS number 144510-96-3
    D.3.9.3Other descriptive namePIXANTRONE
    D.3.9.4EV Substance CodeSUB21304
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.8
    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 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 (DLBCL)
    E.1.1.1Medical condition in easily understood language
    A subtype of non-Hodgkin lymphoma, a tumour disease involving B lymphocytes, a particular type of white blood cells with a key role in immune system
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of rate of complete remission after induction therapy
    E.2.2Secondary objectives of the trial
    Assessment of:
    overall survival, progression-free survival,
    cardiac toxicity, and
    safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained according to international guidelines and local laws
    2. Male or female patients aged ≥ 18 years without upper age limit
    3. Previously untreated and histologically confirmed diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3B according to REAL/WHO classification
    4. At least one objectively bi-dimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion; patients with the following sites of disease are NOT eligible:
    - Patients with only skin lesions or only palpable lymph nodes
    - Patients with spleen or bone marrow as only site of disease
    5. Life expectancy ≥ 3 months according to investigator´s opinion
    6. Ann Arbor stage: II-IV
    7. Ability to understand the nature of the trial and the trial-related procedures and to comply with them
    8. Criteria for stratification:
    Population 1:
    Age ≥ 75 years (without limited cardiac function) not eligible for standard R-CHOP 21 treatment
    or
    Population 2:
    Impaired cardiac function, characterised by:
    First 10 patients:
    Ejection fraction: ≥ 40% and ≤ 50%

    Additional patients:
    Ejection fraction: > 30% and ≤ 50%

    Note: Patients ≥ 75 years of age with impaired cardiac function are eligible for population 2.
    E.4Principal exclusion criteria
    1. Severe pulmonary, hepatic or renal comorbidities which make the patient ineligible for cytotoxic drug treatment
    2. Severe cardiac impairment, e.g. NYHA class IV, (with the exception of inclusion criterion 8), or resting cardiac troponin T levels >0.05 ng/ml (according to > grade 1 CTCAE 3.0) which makes the patient ineligible for cytotoxic drug treatment
    3. Prior treatment for lymphoma other than pre-treatment with steroids
    4. History of indolent lymphoma
    5. Manifestation of DLBCL disease in central nervous system (CNS)
    6. Active hepatitis B or C, serologic positivity for HIV infection
    7. HIV-related lymphoma
    8. Immunisation with live virus vaccines within the last 14 days
    9. Major thoracic and/or abdominal surgery within the 4 weeks before trial registration from which the patient has not fully recovered except for diagnosis of non-Hodgkin lymphoma (NHL); patients who have had minor surgery may be enrolled after a ≥ 1 week recovery period except for diagnosis of NHL
    10. Serious (NCI CTCAE grade 3-4) intercurrent infection at the time of trial registration or deep-seated or systemic mycotic infection.
    11. Active or history of another malignancy except cured basal cell carcinoma of skin or carcinoma in situ of uterine cervix; patients who have been in remission from another previous malignancy for > 5 years will be considered eligible
    12. Known hypersensitivity to pixantrone, or any drugs or excipients of the associated chemotherapy R-CPOP that the patient will receive
    13. Simultaneous participation in other interventional trials and/or participation before the end of a required restriction period
    14. Participation in a clinical trial within the last 30 days before being registered in this trial
    15. Known or persistent abuse of medication, drugs or alcohol
    16. Person who is in a relationship of dependence/employment with the sponsor or the investigator
    17. For female patients of child-bearing potential: current or planned pregnancy, nursing period
    18. Unwillingness to use an adequate contraception method during chemotherapy treatment until six months thereafter:
    for male patients (unless vasectomised):
    18.1 a latex condom during sexual contact with females of childbearing potential
    for female patients of child-bearing potential:
    18.2 mechanical method (female condom, diaphragm or coil) used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
    E.5 End points
    E.5.1Primary end point(s)
    Rate of complete remission after induction therapy as determined by PET-CT 6 weeks after last treatment (EOT visit)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment visit
    E.5.2Secondary end point(s)
    Overall survival:
    time from start of trial treatment to death from any cause, considering patients, where the event of interest has not been observed, as censored observations.

    Progression-free survival:
    time from start of trial treatment to disease progression or death from any cause, whichever occurs first. Patients for whom the event of interest has not been observed are analysed as censored observations.

    Cardiac toxicity:
    echocardiography, ECG, troponin T, NT-proBNP during chemotherapy, at end of treatment and every 3 or 6 months during follow up;
    cardiac AEs according to CTCAE

    Safety:
    Rates of adverse events and serious adverse events according to CTCAE
    E.5.2.1Timepoint(s) of evaluation of this end point
    endpoints:
    Overall survival: continuously during treatment and follow-up
    Progression-free-survival: continuously during treatment and follow-up
    Cardiac toxicity: continuously during treatment and follow-up
    Safety: continously during treatment phase
    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.8.2.4Number 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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    according to the investigator's discretion based on best standard of care
    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 Decision2017-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
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