Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 11:57 PM
Study NCT ID:
NCT04920968
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2021-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C543332', 'term': 'obinutuzumab'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.', 'timeFrame': 'assessed between days 33-34 since start of Induction I'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.', 'timeFrame': 'assessed between days 20-28 since start of last course of consolidation'}, {'measure': 'complete remission rate after Induction I', 'timeFrame': 'assessed between days 33-34 since start of Induction I'}, {'measure': 'Overall complete remission', 'timeFrame': 'in 24month follow up'}, {'measure': 'Probability of overall survival', 'timeFrame': 'in 24 month follow up'}, {'measure': 'Probability of relapse-free survival', 'timeFrame': 'in 24 month follow up'}, {'measure': 'Probability of event-free survival', 'timeFrame': 'in 24 month follow up'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': 'in 24 month follow up'}, {'measure': 'Rate of adverse events', 'timeFrame': 'in 24 month follow up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CD20-positive Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.\n3. Signed written informed consent.\n4. Adequate contraception in case of women with child-bearing potential\n\nExclusion Criteria:\n\n1. Lymphoblastic lymphoma with bone marrow blasts\\<20%.\n2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.\n3. Major surgery within 4 weeks before enrollment.\n4. Impaired cardiac function: ejection fraction \\<40% on echocardiography, QTc interval \\> 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).\n5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus\n6. Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.\n7. Serum creatinine \\> 2 times the upper normal limit of the laboratory, total bilirubin\\> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase \\> 5 upper normal limit, unless related to Acute lymphoblastic leukemia\n8. Intolerance to treatment with monoclonal antibody.\n9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.\n10. Inability to obtain written informed consent.\n11. Inability to comply with regular monitoring.'}, 'identificationModule': {'nctId': 'NCT04920968', 'acronym': 'OVERALL', 'briefTitle': 'Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia/PALG ALL7 "OVERALL"', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': '20-NIO-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obinutuzumab', 'description': 'Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.', 'interventionNames': ['Drug: Obinutuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab', 'description': 'Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Obinutuzumab', 'type': 'DRUG', 'description': 'Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).', 'armGroupLabels': ['Obinutuzumab']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Activ comparator'], 'description': 'Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.)', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bialystok', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jarosław Piszcz, Dr hab.med.', 'role': 'CONTACT', 'email': 'jaroslaw.piszcz@gmail.com', 'phone': '85 831 82 30'}], 'facility': 'Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Brzozów', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jacek Krzanowski, dr n.med', 'role': 'CONTACT', 'email': 'hematologia-sek@szpital-brzozow.pl', 'phone': '13 4309728'}], 'facility': 'Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny', 'geoPoint': {'lat': 49.69501, 'lon': 22.01926}}, {'city': 'Gliwice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Sebastian Giebel, prof. n.med.', 'role': 'CONTACT', 'email': 'Sebastian.Giebel@io.gliwice.pl', 'phone': '32 278 85 23'}, {'name': 'Aleksandra Żuczek', 'role': 'CONTACT', 'phone': '32 278 85 28'}], 'facility': 'Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Grzegorz Helbig, Prof. dr hab. n. med', 'role': 'CONTACT', 'email': 'ohits@spskm.katowice.pl', 'phone': '32 2591 281'}], 'facility': 'Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Kielce', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Ewa Sierlecka, lek.med.', 'role': 'CONTACT', 'email': 'hematologia@onkol.kielce.pl', 'phone': '41 367 4841'}], 'facility': 'Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'city': 'Krakow', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Małgorzata Raźny Dr n. med.', 'role': 'CONTACT', 'email': 'mrazny@rydygierkrakow.pl', 'phone': '+48602731744'}], 'facility': 'Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Legnica', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jadwiga Hołojda, Dr n. med.', 'role': 'CONTACT', 'email': 'jadwiga.holojda@szpital.legnica.pl', 'phone': '505 149 579'}], 'facility': 'Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy', 'geoPoint': {'lat': 51.21006, 'lon': 16.1619}}, {'city': 'Lodz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Szmigielska-Kapłon, Dr hab. n. med', 'role': 'CONTACT', 'email': 'a.szmigielska-kaplon@kopernik.lodz.pl', 'phone': '426895486'}], 'facility': 'Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marek Hus, Prof.dr hab.n.med.', 'role': 'CONTACT', 'email': 'marekhus@umlub.pl', 'phone': '81 53 45 468'}], 'facility': 'Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Wojciech Legieć, Dr n. med', 'role': 'CONTACT', 'email': 'wlegiec@cozl.pl', 'phoneExt': '502074194'}], 'facility': 'Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Olsztyn', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Janusz Hałka, dr n.med.', 'role': 'CONTACT', 'email': 'ord.hematologia@poliklinika.net', 'phone': '89 539 81 30'}], 'facility': 'Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Lidia Gil, Prof. dr hab. n. med.', 'role': 'CONTACT', 'email': 'hematologia.sekretariat@skpp.edu.pl', 'phone': '61 854 93 83'}], 'facility': 'Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Szczecin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Barbara Zdziarska, Prof.dr hab.n.med.', 'role': 'CONTACT', 'email': 'sekr.hemat@spsk1.szn.pl', 'phone': '091 4253347'}], 'facility': 'Klinika Hematologii Pomorskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Torun', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Edyta Cichocka, Dr n.med.', 'role': 'CONTACT', 'email': 'hematologia@med.torun.pl', 'phone': '56 61 00 411'}], 'facility': 'Oddział Hematologii, Specjalistyczny Szpital Miejski', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Gawroński, Prof. dr hab. n. med.', 'role': 'CONTACT', 'email': 'kgawronski@wim.mil.pl', 'phone': '22 261 817 160'}], 'facility': 'Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Ewa Lech - Marańda, Prof. dr hab. n. med.', 'role': 'CONTACT', 'email': 'hemsek@ihit.waw.pl', 'phone': '22 349 63 34'}], 'facility': 'Klinika Hematologii, Instytut Hematologii i Transfuzjologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Grzegorz Basak, Prof. dr hab. n. med.', 'role': 'CONTACT', 'email': 'kho@spcsk.pl', 'phone': '22 599 28 18'}], 'facility': 'Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Czyż, Dr n.med.', 'role': 'CONTACT', 'email': 'khn@usk.wroc.pl', 'phone': '71 784 25 76'}], 'facility': 'Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jarosław Dybko, dr n.med.', 'role': 'CONTACT', 'email': 'jdybko@dctk.wroc.pl', 'phone': '71 78 313 75'}], 'facility': 'Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Sebastian Giebel, prof. dr n.med.', 'role': 'CONTACT', 'email': 'Sebastian.Giebel@io.gliwice.pl', 'phone': '32 278 85 23'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'KCRI', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}