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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-003920-30
    Sponsor's Protocol Code Number:CHARLY
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-003920-30
    A.3Full title of the trial
    Phase-II study on the value of post-transplant Cyclophosphamide
    after Thiotepa-based haplo-identical stem-cell transplantation for relapsed-refractory lymphoma
    Eine Studie zum Stellenwert von Cyclophosphamid nach Thiotepa-Basierter Haplo-identer Stammzelltransplantation für refraktäre non-Hodgkin Lymphome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase-II study on the value of post-transplant Cyclophosphamide
    after Thiotepa-based haplo-identical stem-cell transplantation for relapsed-refractory lymphoma
    Eine Studie zum Stellenwert von Cyclophosphamid nach Thiotepa-Basierter Haplo-identer Stammzelltransplantation für refraktäre non-Hodgkin Lymphome
    A.3.2Name or abbreviated title of the trial where available
    CHARLY
    A.4.1Sponsor's protocol code numberCHARLY
    A.5.4Other Identifiers
    Name:DRKSNumber:DRKS00009880
    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 SponsorUniversity Hospital Heidelberg
    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 supportRiemser Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Heidelberg
    B.5.2Functional name of contact pointDr. med. Sascha Dietrich
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 410
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number00496221568001
    B.5.6E-mailsascha.dietrich@med.uni-heidelberg.de
    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 Cyclophosphamid Trockensubstanz 1g
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder 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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) 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 No
    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
    Myeloablative haplo-identical stem cell transplantation for poor risk non-hodgkin lymphoma
    E.1.1.1Medical condition in easily understood language
    Myeloablative haplo-identical stem cell transplantation for poor risk non-hodgkin lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the probability of PFS defined as the proportion of being alive and free of relapse at 1 year after haplo-HSCT with ptCY
    E.2.2Secondary objectives of the trial
    - To assess the Kaplan-Meier-Estimate probability of PFS over time up to the maximum Follow-up period
    - To assess the combined probability of relapse and non-relapse mortality over time by defining relapse and non-relapse mortality as competing risks to each other
    -To assess the probability of OS defined as the proportion being alive at 1 year after registration with ptCY
    - To assess the Kaplan-Meier-Estimate of OS over time up to the maximum Follow-up period
    - To assess the probability over time and severity of acute and chronic GvHD over time
    -To assess the safety of ptCY
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained according to international guidelines and local laws;
    2. Male or female patients aged 18-65 years;
    3. Diagnosis of one the following NHL subtypes (PTCL, DLBCL, MCL, FL, transformed CLL)
    4. Refractoriness or early relapse (<12 months) after at least two regimens and/or auto-HSCT failure;
    5. Intent-to Thiotepa based myeloablative Haplo-HSCT because of unavailability of a fully matched SIB or MUD (10/10), within the time frame for successful HSCT as determined by disease activity;
    6. ECOG performance status of 0-1;
    7. Ability to understand the nature of the trial and the trial related procedures and to comply with them.
    E.4Principal exclusion criteria
    1. Patients with known congestive heart failure NYHA Class III and IV
    2. Known HIV infection, infectious hepatitis (type B or C) or any other uncontrolled severe infection, i.e. patients with positive HIV test or active hepatitis B should be excluded. Only patients positive anti-HBs+ and anti-HBc+ are allowed to enter the study. Patients with hepatitis C should be excluded;
    3. Known hypersensitivity to cyclophosphamide;
    4. Renally impaired patients with creatinine clearance < 30 ml/min (Cockcroft-Gault equation);
    5. ECOG > 1
    6. Simultaneous participation in other interventional trials; simultaneous participation in registry and diagnostic trials is allowed;
    7. Participation in a clinical trial within the last 14 days before the date of registration of this trial (except for registry and diagnostic trials);
    8. Known abuse of medication, drugs or alcohol;
    9. Female patients who are pregnant or breast feeding;
    10. Fertile patients refusing to use safe contraceptive methods during the study
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival defined as being alive and free of relapse at 1 year post haplo-stem cell transplantation
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year post haplo-stem cell transplantation
    E.5.2Secondary end point(s)
    1. Progression free survival defined as the period between registration and progression or death, whichever occurs first
    2. Time to relapse defined as the period between registration and relapse
    3. Time to non-relapse mortality (NRM) defined as the period between registration and non tumor-related death
    4. Overall survival defined as being alive at 1 year after registration
    5. Overall survival defined as the period between registration and death by any cause
    6. Time to and severity of acute and chronic GvHD post haplo-HSCT
    7. Type, frequency, severity and relationship of adverse events to study treatment, engraftment, infections
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3, 5-7: Day 30, Day 100, Month 6, month 9, month 12 post haplo-stem cell transplantation
    4: 1 year post haplo-stem cell transplantation
    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) 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 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 concerned10
    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 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 years3
    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 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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state35
    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 completion of the trial or trial closure patient’s treatment will be performed according to standards of care.
    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 Decision2016-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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