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    Summary
    EudraCT Number:2007-007056-33
    Sponsor's Protocol Code Number:FL2008 RCHOPGM
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-07-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-007056-33
    A.3Full title of the trial
    An open label, multicenter, non randomized phase II study to evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with RCHOP chemotherapy and Rituximab (MabThera®) maintenance in patients with first-line advanced follicular non Hodgkin’s lymphoma
    A.3.2Name or abbreviated title of the trial where available
    FL2008 RCHOPGM
    A.4.1Sponsor's protocol code numberFL2008 RCHOPGM
    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 SponsorGoelams
    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 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 No
    D.2.1.1.1Trade name leukine
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HEALTHCARE
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLeukine
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) 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
    This study evaluate anti-tumor efficacy and safety of GM-CSF (sargramostim, Leukine®) associated with Rituximab (MabThera®) and chemotherapy (CHOP) in patients with non bulky follicular non Hodgkin’s lymphoma with no prior treatment.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025310
    E.1.2Term Lymphoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the overall tumor response rate of GM-CSF associated with RCHOP (overall objective complete and partial response rates) in patients with follicular lymphoma with no prior treatment
    E.2.2Secondary objectives of the trial
    •To evaluate time to progression (TTP)
    •To evaluate overall survival (OS)
    •To evaluate the duration of response (DR)
    •Time to next treatment (TTNT)
    •To evaluate the safety profile of GM-CSF in association with RCHOP chemotherapy
    •To evaluate FcRs polymorphisms influence on clinical response
    •To monitor FcRs expressing cells in peripheral blood along the treatment
    •To monitor the molecular biological marker bcl-2 (translocation t(14;18) in peripheral blood and bone marrow (quantitative PCR assay)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically confirmed follicular lymphoma grade 1, 2 or 3a (biopsy ≤ 4 months).
    •Patients previously untreated (including treatments with steroids and radiation therapy)
    •Bulky disease at study entry according to the GELF criteria:
    Nodal or extranodal mass > 7cm in its greater diameter
    Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)
    B symptoms
    Elevated serum LDH or β2-microglobulin
    Splenic enlargement
    Compressive syndrome
    Pleural/peritoneal effusion
    •Age must be > 18 years.
    •Performance status < 2 on the ECOG scale (see Appendix 0 page 40).
    •Adequate hematological function (unless those abnormalities are related to lymphoma extension) within 28 days prior to registration, including:
    Hemoglobin ≥ 8.0 g/dL (5.0 mmol/L)
    Absolute neutrophil count (ANC) ≥ 1.0x109/L
    Platelet count ≥ 100x109/L
    •Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
    •Patients with at least one measurable lesion
    •Having previously signed a written informed consent form.
    E.4Principal exclusion criteria
    •Transformation to high-grade lymphoma (secondary to “low-grade” follicular lymphoma).
    •Grade 3b follicular lymphoma.
    •Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).
    •Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone.
    •Patients with prior or concomitant malignancies except nonmelanoma skin cancer or adequately treated in situ cervical cancer.
    •Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
    •Poor renal function: Serum creatinine > 2.0 mg/dL (197 μmol/L),
    •Poor hepatic function: total bilirubin > 2.0 mg/dL (34 μmol/L), AST (SGOT) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
    •Known HIV infection or active HBV or HCV infection ≤ 4 weeks at registration.
    •Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, heart failure). Judgment is up to the investigator.
    •Life expectancy < 6 months
    •Known sensitivity or allergy to murine products
    •Treatment within a clinical trial within 30 days prior to trial entry
    •Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
    E.5 End points
    E.5.1Primary end point(s)
    •Overall response rate (including CR and PR) after induction as defined by international criteria ([1] Appendix 0 page 39)
    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 No
    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 No
    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.8.5The 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 Information not present in EudraCT
    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 state30
    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 Decision2008-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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