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    Summary
    EudraCT Number:2012-005580-27
    Sponsor's Protocol Code Number:ONC-2011-005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-005580-27
    A.3Full title of the trial
    MULTI-CENTER, PHASE II STUDY TO ASSESS THE SAFETY AND EFFICACY OF HAPLOIDENTICAL BONE MARROW TRANSPLANTATION USING REDUCED INTENSITY CONDITIONING (RIC) REGIMEN AND POST-TRANSPLANT CYCLOPHOSPHAMIDE, IN PATIENTS WITH POOR PROGNOSIS LYMPHOMAS.
    Studio multicentrico di fase II per valutare la sicurezza e
    l’efficacia del trapianto aploidentico di midollo preceduto da un regime di condizionamento di intensità ridotta (RIC) e con ciclofosfamide post-trapianto in pazienti con linfoma a prognosi
    sfavorevole.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study designed to assess the safety and efficacy of the use of a reduced-intensity conditioning regimen before transplantation and of cyclophosphamide after transplantation, in patients with poor prognosis lymphoma undergoing bone marrow transplant from a partially identical donor without elimination of lymphocytes T.
    Studio volto a valutare sicurezza ed efficacia dell'impiego di un regime di condizionamento di intensità ridotta prima del trapianto e di ciclofosfamide dopo il trapianto, in pazienti con linfoma a cattiva prognosi sottoposti a trapianto di midollo proveniente da donatore parzialmente identico senza eliminazione dei linfociti T.
    A.4.1Sponsor's protocol code numberONC-2011-005
    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 SponsorISTITUTO CLINICO HUMANITAS
    B.1.3.4CountryItaly
    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 supportRegione Lombardia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO CLINICO HUMANITAS
    B.5.2Functional name of contact pointHumanitas Cancer Center
    B.5.3 Address:
    B.5.3.1Street AddressVia Manzoni, 56
    B.5.3.2Town/ cityRozzano (MI)
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.4Telephone number+ 39028224 4587
    B.5.5Fax number+ 39028224 4591
    B.5.6E-mailluca.castagna@cancercenter.humanitas.it
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namethiotepa
    D.3.4Pharmaceutical form Powder for concentrate 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.3.8INN - Proposed INNTHIOTEPA
    D.3.9.1CAS number 52-24-4
    D.3.9.4EV Substance CodeSUB10985MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namefludarabine
    D.3.4Pharmaceutical form Powder for solution for injection or 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.3.8INN - Proposed INNFLUDARABINE PHOSPHATE
    D.3.9.1CAS number 75607-67-9
    D.3.9.4EV Substance CodeSUB13897MIG
    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 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.IMP: 3
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecyclophosphamide
    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 INNNA
    D.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 4
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecyclophosphamide
    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 INNNA
    D.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 5
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecyclophosphamide
    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 INNNA
    D.3.9.1CAS number 6055-19-2
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB16414MIG
    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
    Patients with lymphomas (any histology) relapsed after high dose chemotherapy and in complete remission or partial remission after the last CT line
    Pazienti con linfoma (qualsiasi istologia) ricaduti dopo la chemioterapia ad alte dosi con supporto di cellule staminali autologhe e in remissione completa o parziale dopo l’ultima chemioterapia
    E.1.1.1Medical condition in easily understood language
    poor prognosis lymphomas
    linfoma a cattiva prognosi
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003908
    E.1.2Term B-cell small lymphocytic lymphoma
    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 PT
    E.1.2Classification code 10003899
    E.1.2Term B-cell lymphoma
    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 PT
    E.1.2Classification code 10008958
    E.1.2Term Chronic lymphocytic leukaemia
    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 PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    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 PT
    E.1.2Classification code 10020206
    E.1.2Term Hodgkin's disease
    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 PT
    E.1.2Classification code 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the activity, taking into account an excess of toxicity, of the procedure of T-replete BM infused after a reduced intensity conditioning (RIC) regimen and post-transplantation Cy, in patients with poor prognosis lymphoproliferative diseases.
    Valutare in pazienti con linfoma a prognosi infausta l’efficacia e la sicurezza della procedura di infusione di midollo T-repleto dopo un condizionamento di intensità ridotta (RIC) e con l’uso di ciclofosfamide post-trapianto,
    E.2.2Secondary objectives of the trial
    To further evaluate the efficacy and safety of the procedure
    Valutare ulteriormente l’efficacia e la sicurezza della procedura
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PATIENT-RELATED CRITERIA
    1. Age 18-70 years old
    2. Karnofsky performance score ≥ 80%
    3. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and DQB1 loci. A minimum match of 5/10 is required. An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant.
    4. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1
    5. Patients with lymphomas (any histology) relapsed after high dose chemotherapy and in complete remission or partial remission after the last CT line.
    a. Hodgkin’s lymphoma.
    Patients refractory to at least 2 CT lines, and included in tandem auto-allo program.
    b. Diffuse large B cell lymphoma
    Refractory to second line salvage chemotherapy (patients in partial remission, stable disease or progressive). These patients have to be in partial remission or complete remission after last CT line, including high dose chemotherapy (auto-allo program).
    Transformed low grade lymphomas
    c. Peripheral T cell lymphoma
    Patients failing to achieve a complete remission after first line CT.
    d. Low grade lymphomas (follicular and non follicular)
    Patients refractory to first R-CT line.
    Patients failing at least 2 lines CT - The duration of last remission should be < 1 year
    e. Chronic lymphatic leukemia.
    Patients with refractory or relapsing (response duration < 1 year) disease after R-Fludarabine CT
    f. Mantle cell lymphoma.
    Patients relapsing or refractory after first line conventional CT.
    6. Absence of HLA identical sibling and 10/10 unrelated donor
    7. Patients with adequate physical function as measured by:
     Hearth FEV fraction ≥ 40%;
     Total bilirubin ≤ 2.5 mg/dl, ALT, AST, and alkaline phosphatase all ≤ 5 x upper limit of normal (ULN);
     Creatinine clearance or GFR by Cockroft-Gault formula ≥ 50 mL/min/1.73m2;
     FEV1,FVC, DLCO ≥ 50% predicted

    DONOR SELECTION CRITERIA
    1. Donors must be HLA-haploidentical first-degree relatives of the patient. Eligible donors include biological parents, siblings, or children, or half-siblings.
    2. Age ≥ 18 years.
    3. Donors must meet the selection criteria as defined by JACIE
    4. Absence of DSA (donor specific antibody against HLA antigens)
    CRITERI CORRELATI AL PAZIENTE
    1. Età tra 18 e 70 anni
    2. Karnofsky performance score > 80%
    3. Tipizzazione HLA
    La tipizzazione HLA sarà eseguita ad alta risoluzione (livello allelico 4 digits) per i loci HLA-A, -B, Cw, DRB1, e DQB1. Il match minimo richiesto è di 5/10. La ricerca di un donatore volontario non è richiesta per un paziente eleggibile per questo protocollo se la situazione clinica necessita di avere a disposizione un donatore in tempi rapidi.
    4. Il donatore ed il ricevente devono essere identici almeno per un allele in ognuno dei seguenti loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
    5. Pazienti con linfoma (qualsiasi istologia) ricaduti dopo la chemioterapia ad alte dosi con supporto di cellule staminali autologhe e in remissione completa o parziale dopo l’ultima chemioterapia.
    a. Linfoma di Hodgkin.
    Pazienti refrattari ad alemeno 2 linee di chemioterapia, ed in inclusi in un programma auto-allo.
    b. Linfoma a grandi cellule B
    Pazienti con malattia refrattaria alla terapia di salvataggio (remissione parziale, malattia stabile o in progressione) dopo valutazione PET. I pazienti devono essere in remissione completa o parziale dopo l’ultima chemioterapia, che può comprendere una chemioterapia ad alte dosi (programma auto-allo).
    Linfoma a grandi cellule B trasformati da un linfoma di basso grado.
    c. Linfoma a cellule T periferiche
    Pazienti che non ottengono la remissione completa dopo la chemioterapia di prima linea.
    d. Linfomi di basso grado (follicolari e non)
    Pazienti refrattari alla terapia di prima linea con rituximab
    Pazienti che sono in recidiva dopo almeno 2 linee di chemioterapia e la durata dell’ultima remissione é < ad 1 anno
    e. Leucemia linfatica cronica.
    Pazienti refrattari o in ricaduta (durata della risposta < 1 anno) dopo chemioterapia con rituximab e analogo delle purine.
    f. Linfoma mantellare.
    Pazienti in ricaduta o refrattari alla terapia di prima linea (senza chemioterapia ad alte dosi).
    6. Assenza di un donatore HLA identico nella fratria o nel registro dei donatori (10/10).
    7. Pazienti con adeguata funzionalità fisica misurata con:
     Frazione d’eiezione cardiaca > 40%
     Bilirubina totale ≤ 2.5 mg/dl, ALT, AST, e FA ≤ 5 x il limite superiore della normale
     Clearance creatinina o GFR calcolata con la formula di Cockroft-Gault > 50 mL/min/1.73m2;
     FEV1,FVC,DLCO > 50% del valore teorico

    CRITERI DI SEZIONE DEL DONATORE
    Il donatore deve essere un parente di primo grado. La sorgente di cellule staminali è il midollo osseo, prelevato in anestesia generale, non crio-preservato salvo in casi discussi con il PI dello studio.
    1. I donatori eleggibili includono i fratelli/fratellastri, genitori, figli, cugini di primo grado
    2. Età ≥ 18 anni.
    3. Criteri di selezione secondo lo standard JACIE
    4. Assenza nel paziente di anticorpi anti HLA del donatore
    E.4Principal exclusion criteria
    1. Presence of HLA-matched, related donor (HLA-A, -B, -DRB1)
    2. Presence of matched unrelated donor (10/10), available on time.
    3. Pregnancy or breast-feeding.
    4. Evidence of HIV infection or known HIV positive serology.
    5. Current uncontrolled bacterial, viral or fungal infection
    6. Evidence of progression of clinical symptoms or radiologic findings.
    7. Prior allogeneic hematopoietic stem cell transplant.
    8. CNS lymphoma localization
    1. Presenza di un donatore HLA identico familiare (HLA-A, -B, -DRB1)
    2. Presenza di un donatore non correlato HLA compatibile (10/10), disponibile in tempo utile.
    3. Gravidanza o allattamento
    4. Evidenza di infezione HIV o sierologia positiva HIV nota.
    5. Presenza di infezioni batteriche, virali o fungine non controllate
    6. Evidenza di progressione da sintomi clinici o riscontri radiologici
    7. Precedente trapianto allogenico con cellule staminali ematopoietiche.
    8. Localizzazione del linfoma nel SNC
    E.5 End points
    E.5.1Primary end point(s)
    1-year progression free survival (PFS)
    sopravvivenza libera da progressione a un anno (progression free survival, PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year from the treatment
    un anno dal trattamento
    E.5.2Secondary end point(s)
    • Neutrophil and platelet recovery
    • Incidence of graft failure
    • Cumulative incidence of acute and chronic GVHD
    • Incidence of infections
    • Cumulative incidence of relapse/progression
    • Treatment related mortality (TRM)
    • Immunological reconstitution
    • Attecchimento dei neutrofili e delle piastrine
    • Incidenza di rigetto
    • Incidenza cumulativa di GVHD acuta e cronica
    • Incidenza di infezioni batteriche, virali, fungine
    • Incidenza cumulativa di recidiva
    • Non relapse related mortality (NRM)
    • Ricostituzione immunologica
    E.5.2.1Timepoint(s) of evaluation of this end point
    controls with different frequencies in the interval between transplantation and the 1-year follow-up visit, according to clinical practice
    controlli effettuati con differenti cadenze nel periodo fra il trapianto e la visita di follow-up a 1 anno, secondo pratica clinica
    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.8.2.4Number of treatment arms in the trial1
    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 concerned7
    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 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
    LVLS where LV = follow-up visit one year after last patient's enrolment
    LVLS dove per ultima visita (LV) si intende la visita di follow-up a un anno dall'arruolamento dell'ultimo paziente
    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 months1
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state47
    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)
    • Clinical evaluation, complete blood count with differential and serum creatinine, Na+, K+, Ca++, Mg+, bilirubin, liver function test, tacrolimus/cyclosporine levels, PCR for cytomegalovirus and EBV and HSV-1: after the 1st year medical controls will be decided on the base of patient clinical status.
    • Complete restaging: every 4 mos during the second year after transplantation, every 6 mos for the third year and then annually.
    • Chimerism: every 30 days until complete chimera
    Valutazione clinica, esame emocromocitometrico completo con differenziale e creatinina sierica, Na, K, Ca, Mg, bilirubina, test di funzionalità epatica, tacrolimus/livelli di ciclosporina, PCR per citomegalovirus e EBV e HSV-1: dopo il primo anno i controlli saranno decisi in base alle condizioni cliniche del paziente.
    • Ristadiazione completa: ogni 4 mesi durante il 2° anno dopo il trapianto, ogni 6 mesi per il 3° anno e poi annualmente.
    • chimerismo: ogni 30 giorni fino a completa chimera
    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 Decision2013-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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