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    Summary
    EudraCT Number:2022-003398-51
    Sponsor's Protocol Code Number:R-Pola-Glo
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-23
    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 - PEI
    A.2EudraCT number2022-003398-51
    A.3Full title of the trial
    A prospective multicenter phase 2 study of the chemotherapy-light combination of intravenous rituximab with the antibody-drug conjugate polatuzumab vedotin and the bispecific antibody glofitamab in previously untreated aggressive B-cell lymphoma patients above 60 years of age ineligible for a fully dosed R-CHOP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective multicenter phase 2 study of the chemotherapy-light combination of intravenous rituximab with the antibody-drug conjugate polatuzumab vedotin and the bispecific antibody glofitamab in previously untreated aggressive B-cell lymphoma patients above 60 years of age ineligible for a fully dose R-CHOP
    Eine prospektive, multizentrische Phase-2-Studie zur chemotherapiearmen Kombination von Rituximab mit dem Antikörper-Wirkstoff-Konjugat Polatuzumab Vedotin und dem bispezifischen Antikörper Glofitamab bei zuvor unbehandelten Patienten mit aggressivem B-Zell-Lymphom über 60 Jahren, die für ein voll dosiertes R-CHOP nicht in Frage kommen
    A.3.2Name or abbreviated title of the trial where available
    R-Pola-Glo
    A.4.1Sponsor's protocol code numberR-Pola-Glo
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05798156
    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 SponsorInstitut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    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 supportRoche Pharma AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportRoche Austria GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    B.5.2Functional name of contact pointIKF
    B.5.3 Address:
    B.5.3.1Street AddressSteinbacher Hohl 2-26
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60488
    B.5.3.4CountryGermany
    B.5.4Telephone number00496976014420
    B.5.5Fax number00496976013655
    B.5.6E-mailr-pola-glo@ikf-khnw.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 Columvi
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGlofitamab
    D.3.2Product code RO7082859
    D.3.4Pharmaceutical form 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 INNGlofitamab
    D.3.9.2Current sponsor codeGlofitamab
    D.3.9.4EV Substance CodeSUB197235
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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.2.1.1.1Trade name GAZYVARO
    D.2.1.1.2Name of the Marketing Authorisation holderF. Hoffmann-La Roche Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameObinutuzumab
    D.3.2Product code RO5072759
    D.3.4Pharmaceutical form 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 INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.3Other descriptive nameGAZYVARO
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 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 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.2.1.1.1Trade name Polivy
    D.2.1.1.2Name of the Marketing Authorisation holderF. Hoffmann-La Roche Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePolatuzumab vedotin
    D.3.2Product code RO5541077
    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 INNPolatuzumab vedotin
    D.3.9.3Other descriptive namePOLIVY
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 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.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderF. Hoffmann-La Roche Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRituximab
    D.3.2Product code RO0452294
    D.3.4Pharmaceutical form 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 INNRituximab
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameMabThera
    D.3.9.4EV Substance CodeSUB12570MIG
    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 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 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
    aggressive large B-cell lymphoma
    E.1.1.1Medical condition in easily understood language
    aggressive large B-cell lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    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 of the trial is to evaluate an estimator of efficacy of the chemotherapy-light combination of glofitimab, polatuzumab vedotin and rituximab in patients with previously untreated aggressive large B-cell lymphoma.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are designed to i.) further characterize the outcome and ii.) to evaluate the safety and tolerability of the chemotherapy-light combination R-Pola-Glo in patients with previously untreated DLBCL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Patient has provided written informed consent and is able and willing to comply with the study protocol and protocol mandated hospitalizations according to ICH and local regulations.
    (2) Patient (male, female, non-binary) is
    a) Age > 80 years, medically fit to receive the combination therapy OR
    b) Age 61-80 years, medical non-fit and not eligible for R-CHOP-like therapies.
    (3) Patient has histologically confirmed aggressive lymphoma.
    Note: transformed follicular lymphoma and composite lymphoma can be included as long as the low-grade component had not obtained treatment.
    (4) Baseline biopsy material is available for central review.
    (5) Female patients considered as women of childbearing potential (WOCBP, see section 5.2.7 for definition) and male patients with female partners considered as WOCPB must
    a) agree to either remain completely abstinent (refrain from heterosexual intercourse) or to use at least one effective contraceptive methods that results in a failure rate of < 1% per year from screening until:
    o At least 4 months after last dose of glofitamab, 9 months after last dose of polatuzumab vedotin, 12 months after last dose of rituximab or 18 months after last dose of obinutuzumab, whichever is longer, if the patient is female
    o At least 4 months after last dose of rituximab, obinutuzumab and glofitamab or 6 months after last dose of polatuzumab vedotin, whichever is longer, if the patient is male
    b) refrain from donating ova (female patients) or donating sperm (male patients) during the same period as stated in a).
    c) in case of male patients with pregnant female partners, remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom to avoid exposing the embryo.
    Female patients who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile, see section 5.2.7) as well as azoospermic male patients do not require contraception.
    (6) Patient did not receive any prior lymphoma therapy.
    Note: Except for a corticosteroid prephase.
    (7) Patient has a ECOG performance status of ≤ 2.
    Note: Subjects with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment (not more than 100 mg steroids/day up to 7 days prior to Cycle 1 Day 1) during the screening phase results in an improvement of ECOG performance status to ≤ 2 prior to enrollment.
    (8) Patient has a life expectancy (in the opinion of the investigator) of at least 12 weeks.
    (9) Patient has adequate liver function:
    a) Total bilirubin ≤1.5 x ULN (≤3 x ULN in patients with Gilbert’s syndrome).
    b) AST (aspartate aminotransferase)/ALT (alanine aminotransferase), ALP (alkaline phosphatase) ≤3 x ULN.
    o Patients with bone marrow or liver involvement: ALP ≤5 x ULN.
    o Patients with documented liver involvement: AST and/or ALT ≤5 x ULN.
    c) Albumin ≥ 2.5 g/dL.
    (10) Patient has adequate hematological function:
    a) Neutrophil count of ≥1.5 x 109 cells/L (1,500/μL).
    b) Platelet count of ≥75 x 109 cells/L (75,000/μL).
    c) Hemoglobin (Hb) ≥9.0 g/dL.
    Note: In case screening procedures are leading to situations that would exclude the patient from study participation (such as Hb value below entry criteria), the patient may still be enrolled into the trial after consultation with the Sponsor.
    d) For patients not receiving therapeutic anti-coagulation: INR or aPTT ≤ 1.5 x ULN).
    (11) Patient has adequate renal function:
    a) Creatinine ≤ 1.5 x ULN, or
    b) Creatinine clearance (CrCl) calculated by Cockroft-Gault formula of ≥ 40 mL/min for patients in whom, in the Investigator’s judgment, serum creatinine levels do not adequately reflect renal function.
    (12) Patient has negative serologic and/or polymerase chain reaction (PCR) test results for:
    a) Acute or chronic hepatitis B (HBV) infection.
    Note: Patients whose HBV infection status cannot be determined by serologic test results (https://www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation.
    b) Hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
    Note: Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.
    (12) Patient has no active SARS-CoV-2 infection
    • patients with positive SARS-CoV-2 antigen or PCR testing within 30 days prior to treatment initiation are not eligible
    • patients with documented SARS-CoV-2 infection within 6 months prior to treatment initiation must have no persistent respiratory symptoms, no evidence of residual sequelae, and have negative PCR for SARS-CoV-2
    E.4Principal exclusion criteria
    (1) Patient with CLL, ALL; including CD20+ ALL, lymphoblastic lymphoma, Richter`s transformation, Burkitt lymphoma.
    (2) Patient ≤ 60 years
    (3) Patient with known active infection, or reactivation of a latent infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, EBV, CMV, hepatitis B, hepatitis C, and HIV], fungal, mycobacterial, or other pathogens (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 prior to study enrollment.
    (4) Patient with current > Grade 1 peripheral neuropathy.
    (5) Patient with history of confirmed PML.
    (6) Patient with history of leptomeningeal disease.
    (7) Patient with current or history of CNS lymphoma.
    (8) Patient with current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Exceptions are allowed fot this trial.
    (9) Patient with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence), with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%), such as adequately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
    (10) Patient with significant or extensive history of cardiovascular disease (such as NYHA Class ≥ II cardiac disease, [...]) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
    (11) Patient with active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (see addendum for a more comprehensive list of autoimmune diseases and immune deficiencies), with exceptions.
    (12) Patient with uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
    (13) Patient with history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic.
    (14) Patient received treatment with any other standard anti-cancer radiotherapy/chemotherapy including investigational therapy (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks or five times the elimination half-life of the product, whichever is longer, prior to study enrollment.
    (15) Patient with prior solid organ transplantation.
    (16) Patient with prior allogeneic stem cell transplantation.
    (17) Patient with prior treatment with targeted therapies (e.g., tyrosine kinase inhibitors,[...]) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to study enrollment.
    (18) Patient with toxicities from prior anti-cancer therapy including immunotherapy that did not resolve to ≤ Grade 1 except for alopecia, endocrinopathy managed with replacement therapy and stable vitiligo.
    (19) Patient with any history of immune related ≥ Grade 3 AE except for endocrinopathy managed with replacement therapy.
    [...]
    (23) Patient with history of illicit drug or alcohol abuse within 12 months prior to screening, in the Investigator’s judgment.
    (24) Patient with history of severe allergic anaphylactic reactions to chimeric or humanized monoclonal antibodies or recombinant antibody-related fusion proteins. Please consult Lead Investigator if the patient has documented history of CRS or HLH at previous treatments.
    (25) Patient with known hypersensitivity to CHO cell products or to any component of the rituximab, obinutuzumab, polatuzumab vedotin and/or glofitamab formulation and/or to the contrast agents used in the study.
    (26) Female patient is pregnant or breast feeding. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment.
    (27) Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
    (28) Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
    (29) Patients who are dependent on the sponsor, the investigator or the trial site.
    E.5 End points
    E.5.1Primary end point(s)
    1 year progression-free survival (PFS) rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis of the primary efficacy endpoint and the secondary endpoints will be performed following recruitment of all analyzable patients and with adequate observation time to assess the 1-years PFS rate.
    E.5.2Secondary end point(s)
    i.) Outcome-related corresponding endpoints
    • Event-free survival (EFS)
    • Overall survival (OS)
    • Response rates after 2 cycles (during target dose phase), 6 cycles (end of target dose phase before start of maintenance) and 12 cycles (end of treatment following completion of maintenance). i.e., complete remission rate , partial remission (PR) rate, overall remission rate (ORR: CR+PR), stable disease (SD) rate and progression disease (PD) rate
    • Relapse rate
    • Conversion rate of PRs to mCRs during target dose (C2-C6) and maintenance phase (C6-C12)
    • Duration of response (DoR)

    ii.) Safety, tolerability and protocol adherence-relpated corresponding endpoints:
    • Rate and type of adverse events (AEs) and serious adverse events (SAEs)
    • Rate of secondary malignancies
    • Treatment-related death rate
    • Protocol adherence
    • Patient-reported outcomes for quality of life (QoL) as measured by EORTC QLQ-C30 and FACT-Lym
    • Ratio and patient characterisitcs of patients in cohort I vs. cohort II
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analysis will be performed after all enrolled patients have completed the follow up and all study documentation as well as the correction of all CRFs has been completed (database lock).
    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 concerned24
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    The date of database closure is defined as the global end of the trial to ensure the collection of survival data of patients and the active involvement of sites in the data cleaning process.
    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 months54
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months54
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    The investigators of the study are experienced hematologists and oncologists who treat patients in routine clinical practice. Therefore, the investigators are responsible for the further treatment of the patient after the end of the study treatment for disease progression.
    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 Decision2023-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
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