Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-003849-18
    Sponsor's Protocol Code Number:CMC-R-GEMOX
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-003849-18
    A.3Full title of the trial
    A MULTI-CENTER, PHASE IB/II, OPEN LABEL, SINGLE ARM STUDY OF INOTUZUMAB OZOGAMICIN PLUS RITUXIMAB (R-CMC544) ALTERNATING WITH GEMCITABINE-OXALIPLATIN PLUS RITUXIMAB (R-GEMOX) IN PATIENTS AGED FROM 18 TO 80 YEARS WITH CD20 AND CD22 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) IN RELAPSE AFTER/REFRACTORY TO 1ST OR 2ND LINE TREATMENT, WHO ARE NO CANDIDATES FOR AUTOLOGOUS TRANSPLANT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficacy and safety of the combination of rituximab and CMC544 with rituximab, gemcitabine and oxaliplatine in diffuse large B-cell lymphoma at first or second relapse.
    A.3.2Name or abbreviated title of the trial where available
    CMC-R-GEMOX
    A.4.1Sponsor's protocol code numberCMC-R-GEMOX
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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 supportPfizer
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointElise Hutasse
    B.5.3 Address:
    B.5.3.1Street AddressLYSARC-Centre Hospitalier Lyon Sud - Secteur Ste Eugénie
    B.5.3.2Town/ cityPierre Bénite
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472669333
    B.5.5Fax number+33472669371
    B.5.6E-mailelise.hutasse@lysarc.org
    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 nameinotuzumab ozogamicin
    D.3.2Product code CMC544
    D.3.4Pharmaceutical form Powder and solution 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 INNinotuzumab ozogamicin
    D.3.9.2Current sponsor codeCMC-544
    D.3.9.3Other descriptive namePF-05208773
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 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.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
    CD20 and CD22 positive diffuse large B-cell lymphoma in first or second relapse or refractory to first and/or second line treatment
    E.1.1.1Medical condition in easily understood language
    refractory 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 17.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 of the phase Ib part of the study is to determine the tolerability, safety and MTD or recommended dose of R-CMC544 alternating with RGEMOX in subjects aged from 18 to 80 years with CD20 and CD22 positive DLBCL in relapse after/refractory to 1st or 2nd line treatment, who are no candidates for autologous transplant.
    The primary objective of the phase II part of the study is to assess the efficacy or RCMC544 alternating with R-GEMOX as measured by the overall response rate (ORR) by IWG criteria (Cheson 1999) at the end of treatment (after complete treatment or at withdrawal).
    E.2.2Secondary objectives of the trial
    The secondary objective is to obtain preliminary information on the antitumor activity of R-CMC544 alternating with R-GEMOX measured by:
    – the overall response rate (ORR) after induction according to Cheson 1999,
    – the overall response rate (ORR) after induction and at the end of treatment according to Cheson 2007,
    – complete response rate (CRR) at the end of treatment according to Cheson 2007,
    – progression free survival (PFS),
    – event free survival (EFS),
    – overall survival (OS).
    – Duration of Response (DOR)
    – Time to Progression (TTP)

    Exploratory objectives:
    - To compare anti-tumor activity in function of previous rituximab treatment, delay of relapse (more or less than 6 months (is used further in protocol) and 1 year from the end of previous treatment) and secondary IPI 0 1 2 vs 3 4 5.
    - To assess the impact of germinal center (GCB) versus non-germinal center (non-
    GCB)/activated B-cell (ABC) phenotype on response to R-CMC544 alternated with RGEMOX.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically documented CD20 and CD22 positive diffuse large B-cell lymphoma, according to WHO classification. Prior CD20 and CD22 immunophenotyping is acceptable. If such prior documentation is not available, then the immunophenotype of the current disease must be documented by fine-needle aspirate or biopsy or by circulating CD20 and CD22 positive non-Hodgkin lymphoma (NHL) cells from peripheral blood during screening. In case of relapse or partial response the disease must be histologically or cytologically proven.
    Upon registration the anapath report confirming the diagnosis, must be available.
    During the trial the tumor tissue biopsy must be made available for confirmation of the disease.
    - In first or second relapse or refractory to first and/or second line treatment. Refractory is defined as less than PR to a prior rituximab containing regimen or relapse within 6 months of the last dose of a prior rituximab containing regimen.
    - Not eligible for autologous transplantation.
    - Previously treated with a chemotherapy regimen containing anthracyclines and rituximab.
    - Aged 18 - 80 years.
    - ECOG performance status 0 to 2.
    - Minimum life expectancy of 3 months.
    - Signed written informed consent.
    E.4Principal exclusion criteria
    - Burkitt, mantle cell and T-cell lymphomas.
    - Central nervous system or meningeal involvement by the lymphoma.
    - Contraindication to any drug contained in the R-GEMOX combination chemotherapy.
    - Treatment with any investigational drug within 30 days before the first planned cycle of chemotherapy and during the study.
    - Nitrosurea or mitomycin C administration within 6 weeks prior to study start.
    - Major debulking surgery within 3 weeks of treatment.
    - Any of the following lab abnormalities (unless related to the lymphoma or bone marrow infiltration):
    – Absolute neutrophil count (ANC) < 1.500/µL (1,5.109/L).
    – Platelet count < 100.000/µL (100.109/L).
    – Creatinine level > 150 µmol/L (1,7 mg/dL) or 1,5 – 2,0x ULN.
    – Total bilirubin level > 30 µmol/L (1,8 mg/dL) or 1,5x ULN.
    – Serum AST/SGOT or ALT/SGPT >2,5x ULN.
    - Documented infection with HIV, active hepatitis B or C infection.
    - Any serious active disease or co-morbid medical condition that, according to the investigator’s decision, will substantially increase the risk associated with the subject’s participation in the study. Prior history of malignancies other than lymphoma with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or stage 0 (in situ) cervical carcinoma unless the subject has been disease-free for 5 or more years.
    - LVEF less than 50% (measured by echocardiography or scintigraphy).
    - Previous myocardial infarction or pulmonary hypertension within 6 months before the first dose of investigational product.
    - Congestive heart failure NYHA stage III or IV
    - Known chronic liver disease (eg. Cirrhosis) or suspected alcohol abuse.
    - Pregnant or lactating females
    - Men and women who are biologically capable of having children not willing to use an adequate method of birth control during the study and up to 18 months after the last dose of investigational product.
    - Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the Recommended Dose of R-CMC544 alternating with R-GEMOX
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of Cycle 2 (after 14 or 16 weeks).
    E.5.2Secondary end point(s)
    - overall response rate (ORR) after induction according to Cheson 1999,
    - overall response rate (ORR) after induction and at the end of treatment according to Cheson 2007,
    - complete response rate (CRR) at the end of treatment according to Cheson 2007,
    - progression free survival (PFS),
    - event free survival (EFS),
    - overall survival (OS).
    - Duration of Response (DOR)
    - Time to Progression (TTP)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of cycle 4 for ORR.
    From the date of inclusion to the date of first documented disease progression or death from any cause for PFS and OS.
    From the date of inclusion to the date of documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Determination of the recommended dose of R-CMC544 alternating with R-GEMOX
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years5
    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 years5
    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) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 treated according to local practice.
    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 Decision2012-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-22
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 19:50:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA