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    Summary
    EudraCT Number:2009-014844-13
    Sponsor's Protocol Code Number:50-2009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-12-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-014844-13
    A.3Full title of the trial
    Phase I/II clinical trial with Bendamustine and Temsirolimus in patients with relapsed or refractory mantle cell lymphoma that are not eligible for high dose chemotherapy and stem cell transplantation.
    A.3.2Name or abbreviated title of the trial where available
    Bendamustine and Temsirolimus in relapsed or refractory mantle cell lymphoma
    A.4.1Sponsor's protocol code number50-2009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCharité Universitätsmedizin Berlin
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Torisel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth
    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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/058/06
    D.3 Description of the IMP
    D.3.1Product nameTemsirolimus
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTEMSIROLIMUS
    D.3.9.1CAS number 162635-04-3
    D.3.9.2Current sponsor codeCCI-779
    D.3.9.3Other descriptive name-
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Treatment ot mantle cell lymphoma patients in first or second relapse or refractory disease. Patients should not be eligible for high dose chemotherapy with autologous or allogenous stem cell transplantation.

    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Dose finding (phase I of the clinical trial): is the combination of temsirolimus with bendamustine at the suggested doses feasible or are dose reductions necessary.
    - Resonse rate (overall response rate (ORR), complete remissions (CR), partial remissions (PR) (phase II part of the clinical trial): what is the response rate of a treatment with temsirolimus alongside with bendamustine.
    E.2.2Secondary objectives of the trial
    - Duration of progression free survival (PFS)
    - Safety and tolerability: Assessment of serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Histologically proven mantle cell lymphoma
    3. First or second relapse or progression during treatment. A prior treatment with bendamustine ist feasible, if the patient achieved at least a partial response and progression free survival lasted at least six months. A prior high dose chemotherapy with autologous stem cell transplantation is feasible, if the patient achieved at least a partial response and progression free survival lasted at least twelve months.
    4. Patients are not eligible for high dose chemotherapy and autologous or allogenous stem cell transplantation.
    5. Sufficient bone marrow reserve (hemoglobuline > 9 g/dL, thrombocytes > 100/nL, neutrophile granulocytes > 1.5/nL)
    6. WHO/ECOG performance status 0 – 2
    7. Measurable disease (two perpendicular diameters in radiologic evaluation)
    8. Life expectancy of at least three months
    9. Written consent
    E.4Principal exclusion criteria
    1. Prior treatment with an mTOR inhibitor
    2. Severe concomitant disease (e.g. severe cardiac insufficiency, myocardial infarction within the last six months prior to inclusion into the clinical trial, uncontrolled arterial hypertension, renal failure requiring dialysis, severe lung disease, severe liver disease, severe diabetes mellitus)
    3. Disturbed liver function: transaminases or total bilirubine > 2 x upper limit of normal
    4. Disturbed kidney function: serum-creatinine > 2 x upper limit of normal
    5. Coexistant or prior malignant tumor within the last three years with the exception of an adequately treated basal cell carcinoma or a cervical carcinoma in situ.
    6. Concomitant treatment with strong inducers or inhibitors of CYP3A4
    7. Women, pregnant or breast feeding, may not be included into the trial. The same applies for fertile patients, women and men alike, that are not willing to perform an efficient contraception. An effective contraception has a failure rate below 1% per year (e.g. sexual abstinence or vasectomy). Fertile women have to have a negative pregnancy test that is not older than seven days.
    8. Bigger surgical procedures within the last four weeks prior to inclusion. Smaller surgical procedures (e.g. implantation of an i.v. portal catheter) within one week prior to inclusion.
    9. Prior treatment in a clinical trial within the last four weeks prior to inclusion into the clinical trial.
    10. Concomitant immunotherapy (e.g. Rituximab) or chemotherapy except bendamustine. The usage of systemic steroids should be documented and reported to the leading clinical trial center.
    11. CNS-manifestation
    12. HIV-positivity
    13. Active or inactive hepatitis B or hepatitis C infection
    14. Severe psychiatric disease
    15. Individuals that are placed into an institution due to magisterial or judicical order
    16. Incapacity to follow the protocol requirements
    E.5 End points
    E.5.1Primary end point(s)
    - Dose finding (phase I of the clinical trial): is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Temsirolimus is administered at the concentration that proved to be efficient in a recent phase three trial. Temsirolimus has been licensed for treatment of relapsed mantle cell lymphoma at this dose.
    - Response rate (overall response rate (ORR), complete remissions (CR), partial remissions (PR) (phase II of the clinical trial: what is the response rate of a therapy with temsirolimus and bendmustine.
    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 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 concerned3
    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 Information not present in EudraCT
    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
    If the patient does not progress during treatment with temsirolimus and bendamustine, he/she is treated for six cycles à 28-days with this combination. Subsequently, controls are planned for 24 months. Patients that have achieved at least a partial response to temsirolimus and bendamustine, will receive a maintenance therapy with temsirolimus alone until disease progression.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.3Elderly (>=65 years) Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    Fertile women have to be willing to perform an effective method of contraception and have to have a negative pregnancy test that is not older than seven days upon inclusion into the clinical trial.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Therapy according to the suggestions of the treating physician in accordance with 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 Decision2010-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-03-17
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