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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2007-001103-37
    Sponsor's Protocol Code Number:B020999
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-08
    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 - PEI
    A.2EudraCT number2007-001103-37
    A.3Full title of the trial
    An open-label, multicentre, non-randomised, dose-escalating phase I/II study, with a randomized phase II part, to investigate the safety and tolerability of RO5072759 given as monotherapy in patients with CD20+ malignant disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Dose-Escalating Study of RO5072759 in Patients With CD20+ Malignant Disease
    A.4.1Sponsor's protocol code numberB020999
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstr. 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 nameRO5072759/F01
    D.3.2Product code RO5072759/F01
    D.3.4Pharmaceutical form Powder 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.3.9.2Current sponsor codeRO5072759/F01
    D.3.9.3Other descriptive nameGA101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeRO5072759 is a humanized and glycoengineered monoclonal antibody (mAb)
    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
    For the phase I and II parts of the study, patients with CD20+ malignant disease for whom no therapy of higher priority is available and where treatment with an anti-CD20 antibody is deemed appropriate will be enrolled.

    For the phase II part of the study, patients with either, relapsed/refractory CD20+ indolent NHL, relapsed/refractory aggressive NHL and relapsed/refractory B-CLL will be enrolled.
    E.1.1.1Medical condition in easily understood language
    Lymphomas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024340
    E.1.2Term Leukemia lymphocytic chronic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025311
    E.1.2Term Lymphoma (non-Hodgkin's)
    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 for the phase I part of the study is: • To investigate the safety and tolerability of escalating intravenous (IV) doses of RO5072759 given as monotherapy in patients with CD20+ malignant solid and leukemic disease (i.e., B-CLL and NHL patients). The primary objective for the phase II part of the study is: • To investigate the efficacy and safety of two doses of RO5072759 (low and high dose) in 2 patient populations: relapsed/refractory indolent NHL and relapsed/refractory aggressive NHL. • To investigate the efficacy and safety of one dose of R05072759 (1000mg) in patients with relapsed/refractory B-CLL
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows: • To characterize the pharmacokinetics of RO5072759 • To examine peripheral blood B-cell depletion and recovery with increasing doses of RO5072759 • To obtain preliminary data on the anti-tumor efficacy of RO5072759 given as monotherapy in patients with relapsed/refractory indolent NHL, relapsed/refractory aggressive NHL and relapsed/refractory B-CLL by evaluating: - overall response rate (ORR) - progression-free survival (PFS) - event-free survival (EFS) • To investigate pharmacogenetic parameters (including but not limited to FcγR IIa and IIIa and stromal derived factor-1 [SDF-1] polymorphisms) and pharmacodynamic parameters (including but not limited to bcl-2 rearrangements) in relation to efficacy
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    All patients who have been enrolled in the study will be asked to participate in the Roche Sample Repository Project in countries where RSR sampling is to be undertaken. The RSR project involves taking a 9 mL blood sample for pharmacogenetic and genetic research. Taking part in the RSR project is entirely optional and subject to a separate signed informed consent document.
    E.3Principal inclusion criteria
    Patients in the Phase I part of the study must meet the following criteria: 1. Have documented CD20+ malignant disease (B-cell lymphoma or B-CLL [B-CLL confirmed by NCI Working Group Criteria, 2008) for which no therapy of curative or high priority exists and for whom treatment with an anti-CD20 antibody may be appropriate. For each patient, a prior biopsy demonstrating CD20 positivity of tumour cells must be available locally prior to dosing, and will be further confirmed following central review (For B-CLL patients confirmation of CD20+ status must be performed by flow cytometry. Patients with small lymphocytic lymphoma [SLL], must have CD20+ status confirmed by histopathological evaluation of a lymph node biopsy). Ideally, where feasible during the course of the study, confirmation that the disease remains CD20+, should be obtained (Fine needle aspiration cytology [FNAC] is sufficient for this purpose where feasible). In addition, where available, the initial diagnostic biopsy will also be reviewed centrally. 2. Have either: • Relapsed or refractory indolent NHL • Relapsed or refractory aggressive NHL • Relapsed or refractory B-CLL 3. All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by computerized tomography [CT] scan). In addition, where appropriate, for CLL patients, circulating lymphoctye cell assessments will be performed. Note that all measurable and evaluable disease must be assessed and documented prior to initiation of RO5072759 treatment. Tumor response will be based on the status of all areas of disease. Patients in both Phase I and II parts of the study must also meet the following criteria to be eligible for study entry: 4. Able and willing to provide written informed consent and to comply with the study protocol. 5. Have a clinical indication for treatment as determined by the investigator 6. Age >18 years. 7. ECOG performance status of 0-2 8. Life expectancy >12 weeks
    E.4Principal exclusion criteria
    Patients in both Phase I and II portions who meet any of the following criteria at screening will be excluded from the study: 1. Prior use of any investigational monoclonal antibody therapy or other agent within 6 months of study start 2. Prior use of any anti-cancer vaccine 3. Prior use of standard anti-lymphoma/leukemia therapy or radiation therapy within 4 weeks of enrollment 4. Prior administration of rituximab within 56 days of study entry. However, for those patients with aggressive disease (DLBCL and MCL) and any other patient, where immediate treatment is mandated, a rituximab wash-out period of 28 days will be considered acceptable. This will be approved by the Sponsor on a case by case basis. 5. Prior administration of radioimmunotherapy 3 months prior to study entry 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products. 7. Central nervous system lymphoma 8. History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for ≥2 years prior to enrollment. 9. Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm). 10. Known active bacterial, viral (including human immunodeficiency virus [HIV]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of receiving the first dose of RO5072759 11. Recent major surgery (within 4 weeks prior to receiving first dose of RO5072759), other than for diagnosis. 12. Any of the following abnormal laboratory values: Renal – Calculated creatinine clearance by Cockcroft-Gault formula ≤ 50 mL/min for NHL patients, or ≤ 60 mL/min for the first 3 B-CLL patients enrolled in cohort 4b (See Appendix 5). The restriction of ≤ 60 mL/min for the first 3 B-CLL patients, may be modified for subsequent cohorts (i.e., reduced or increased) based upon review of the ongoing safety data but the calculated creatinine clearance should not be ≤ 50 mL/min. 13. Presence of positive test results for: - Human immunodeficiency virus (HIV), - Hepatitis B (HB virus [B DNA], HB surface antigen [HBsAg], total HB core antibody [anti-HB-c] - Hepatitis C (Hepatitis C virus [HCV] antibody serology testing. 14. Women who are pregnant or lactating. 15. Fertile men or women of childbearing potential unless (1) surgically sterile or (2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly. Effective contraception is required throughout the study and (because of the long half-life of humanized monoclonal antibodies and the potential for prolonged lymphopenia) for at least 12 months after the last dose of RO5072759 16. Treatment within a clinical study within 30 days prior to study entry. 17. Ongoing corticosteroid use with the exception of corticosteroid use for other indications, is permitted up to a maximum dose of 30 mg/day prednisone or equivalent. 18. Patients will be excluded from the phase II part of the study if they have histological evidence of transformation of disease. For B-CLL patients, patients will be excluded from the phase II part of the study, if transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter’s syndrome, or prolymphocytic leukaemia (PLL) occurs. However, for the phase I part of the study, patients with a history of, or who have a recent transformation of disease, will be considered eligible, for, as long as the disease remains CD20+
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint – Phase I part of the Study The primary endpoint for the phase I part of the study will be the incidence of DLTs. The number of patients with DLTs in each cohort will be summarized in listings for patients with NHL (i.e., relapsed/refractory fNHL, DLBCL, MCL) and patients with relapsed/refractory B-CLL. This endpoint will be assessed only in the phase I part of the study. Primary endpoint – Phase II part of the Study The primary endpoint for the phase II part of the study will be overall response rate. Overall response rate will be analysed in frequency tables including 95% Pearson-Clopper confidence intervals and 95% and 80% confidence intervals for the difference in response rate between the low and the high RO5072759 dose group. Analysis will be done by indication (NHL or B-CLL) with further subgroup analyses for the first group by indolent and aggressive NHL patients. For phase I data, this endpoint will be analysed by cohort
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint – Phase I part of the Study Event Driven Primary endpoint – Phase II part of the Study Event Driven
    E.5.2Secondary end point(s)
    1. Complete and partial response rates, progression-free survival 2. AEs, laboratory parameters, pharmacokinetic and pharmacodynamic parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Event driven
    2. Event driven
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    Biomarkers analysis
    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 Yes
    E.8.1.1Randomised Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial5
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The recruitment to the phase I part of the study took approximately 12 months. The recruitment to the phase II part of the study took approximately 9 months. All patients will receive a maximum of 8 Cycles of treatment with RO5072759 (i.e., 24 weeks). The end of the study is defined as 2 years after the last patient has entered the re-treatment unless all patients have left the study prior to this point
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 134
    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)
    After the subject has finished in the study they will either have progression leading to death, not receive any further treatment and only terminal care or other treatment at the discretion of each investigator.
    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 Decision2008-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-03
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