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   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).

    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:2006-006152-34
    Sponsor's Protocol Code Number:EFC6663
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-006152-34
    A.3Full title of the trial
    A Multicenter, Open-Label, Single Arm Study of Weekly Alvocidib in Patients with Previously Treated B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) Arising from CLL
    A.4.1Sponsor's protocol code numberEFC6663
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance, Metropolitan
    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 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.2.5The 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 nameAlvocidib
    D.3.2Product code HMR1275
    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 INNalvocidib
    D.3.9.1CAS number 131740-09-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 mg /ml
    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
    B-Cell Chronic Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia (PLL) arising from CLL
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10009310
    E.1.2Term CLL
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective overall response rate (CR+PR including nPR) of alvocidib administered as a 30 minute infusion followed by a 4 hour continuous infusion in previously treated CLL patients or Prolymphotic Leukemia (PLL ) arising from CLL.
    E.2.2Secondary objectives of the trial
    To assess the objective overall safety profile of this treatment.

    To assess the response duration, progression free survival (PFS) and overall survival (OS) following this treatment.

    To assess the clinical benefit by assessing:
    - Reduction in incidence and severity of B-symptoms and time to relief of B-symptoms;
    - Reduction in the frequency and amount of blood and platelet transfusions;
    - Reduction in incidence of cytomegalovirus (CMV) reactivation and other opportunistic infections.

    To assess the pharmacokinetics of this schedule of administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must have documentation of histologically confirmed CLL, or PLL arising from CLL as established by the NCI Working Group Response Criteria (NCI 96 criteria) for diagnosis of CLL.

    2. Patient must have symptomatic Rai Stage III or IV, or Binet Stage B or C. (Patient will also be eligible if presented with Rai stage I, II or Binet Stage A, accompanied by rapid doubling time of peripheral lymphocyte count, or symptomatic splenomegaly/hepatomegaly or symptomatic or progressive lymphadenopathy or B-symptoms).

    3. Patient must have progressive or symptomatic disease as defined by any of the following conditions:
    - Progressive lymphocytosis with a lymphocyte count increased > 50% over last 2 month period or an anticipation of the doubling time in less than 6 months;.
    - symptomatic splenomegaly/hepatomegaly
    - symptomatic or progressive lymphadenopathy
    - Anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelets < 100 x 10 9/L) within past 6 months.
    - Presence of any B-symptoms:
    Weight loss ≥ 10% within the previous 6 months; extreme fatigue or inability to perform work or usual activities; Fevers > 100.5 °F (38 °C) for ≥ 2 weeks without evidence of infection; night sweats without evidence of infection.
    4.Patient must have received one or more prior therapies for CLL or PLL arising from CLL. All patients:
    - must have received prior alkylating agent(s) and be fludarabine refractory either as a single agent or in combination with other chemotherapy agents. Examples of prior chemotherapy regimen(s) include:
    -chlorambucil (pulse or continuous) ± prednisone
    -cyclophosphamide ± prednisone
    -CVP (cyclophosphamide, vincristine, prednisone)
    -FC (fludarabine, cyclophosphamide) ± rituximab
    -fludarabine ± rituximab
    -Fludarabine refractory CLL is defined as:
    Stable disease (lack of an objective PR or CR) after at least 2 cycles of fludarabine-based therapy;
    Progressive disease on therapy or ≤ 6 months following completion of fludarabine-based therapy.
    -Patient may have received any of the following prior treatment regimens, or be intolerant, or not an appropriate candidate for such treatment:
    (alemtuzumab single agent or in combination,rituximab or pentostatin incombinations)
    5.Patients must have the adequate organ functions
    White Blood Cells (WBC) ≤ 150 x 10 9/L,Serum Creatinine < 2 mg/dl, or Creatinine clearance >70 mL/min AST and/or ALT < 2.5 x ULN (higher values due to hemolysis or disease infiltration of the liver are allowed)
    6..Patient’s age must be ≥ 18 years.
    7.Patient’s ECOG performance status must be 0-2
    8.Women of child bearing potential must have a negative serum pregnancy test 14 days prior to administration of the study drug. Men and women who are fertile and are of child bearing potential and their partner must use highly effective contraception (highly effective method of birth control is defined as those which result in low failure rate (<1% per year )when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IDUs, sexual abstinence, or vasectomized partner )
    E.4Principal exclusion criteria
    1. Patient with de novo PLL.
    2. Patient with secondary malignancy that will limit survival to less than 5 years.
    3. Patient received prior alvocidib treatment.
    4. Patient with prior allogenic or autologous bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) less than 12 months. (Patients with chronic GVHD and/or currently receiving immunosuppresants must be excluded)
    5. Patient receiving an investigational agent or an approved agent for an investigational purpose within last 6 weeks prior to study registration.
    6. Patient receiving any anticancer agents (chemotherapy, immunotherapy, or targeted agents) within last 6 weeks prior to study registration. (Non-chemotherapeutic treatment for the progressive disease or side effects from the prior treatment is allowed at the discretion of the investigator)
    7. Patient receiving chronic steroids.
    8. Patient with known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency of history of hemolysis indicative of G6PD deficiency. (G6PD deficiency is a contraindication for rasburicase. Patient at high risk (e.g. African or Mediterranean ancestry) with no known history of G6PD deficiency may be screened prior to rasburicase administration at the discretion of the investigator)
    9. Patient with autoimmune hemolytic anemia.
    10. Patient who underwent any major surgery within last 30 days prior to study registration.
    11. Patient with known CNS involvement.
    12. Patient with uncontrolled or poorly controlled high blood pressure, unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association Classification III or IV), severe cardiac arrhythmia or myocardial infarction within the last 6 months.
    13. Patient with active, uncontrolled serious bacterial, viral or fungal infections.
    14. Patient with intercurrent illness such as uncontrolled diabetes, uncontrolled seizure disorders requiring anti-convulsant therapy or severe chronic obstructive pulmonary disease.
    15. Patient with active hepatitis or HIV positive and/or receiving anti-retroviral therapy.
    16. Life expectancy of less than 3 months.
    17. Patient not willing to sign informed consent form.
    18. Patient who is pregnant or breast feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Overall objective response rate (CR + PR including nPR) will be assessed using “hybrid” criteria (CT scan for assessment of nodal disease in combination with NCI 96 criteria for assessment of liver and spleen, constitutional symptoms, peripheral blood +/- bone marrow.)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months21
    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 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 165
    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 Decision2008-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-06
    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 19 01:18:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA