Acute Myeloid Leukemia Clinical Trial
Official title:
Phase III Study of Chemotherapy in Combination With ATRA With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia and NPM1 Gene Mutation
Verified date | February 2023 |
Source | University of Ulm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation. Before Amendment No. 4 (December 2013): Primary Efficacy Objective: - Evaluation of efficacy based on event-free survival (EFS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1) After Amendment No. 4 (December 2013): Primary Efficacy Objective: - Evaluation of efficacy based on overall survival (OS) after induction and consolidation chemotherapy plus all-trans retinoic acid (ATRA) with or without gemtuzumab ozogamicin (GO) in adult patients with acute myeloid leukemia (AML) and mutant nucleophosmin-1 (NPM1)
Status | Completed |
Enrollment | 600 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification. - Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories. - Age = 18 years. There is no upper age limit. - No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 5 days during the diagnostic screening phase. - Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration. - Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and within one year after the last dose of chemotherapy. - Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control: one highly effective method (e.g., IUD, hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap). - "Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months. - Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy. - Signed written informed consent. Exclusion Criteria: - AML with other recurrent genetic changes (according to WHO 2008): - AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 - AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 - AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA) - AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL) - AML with t(6;9)(p23;q34); DEK-NUP214 - AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1. - Performance status WHO > 2. - Patients with ejection fraction < 50% by MUGA or ECHO scan within 14 days of day 1. - Organ insufficiency: - creatinine > 1.5x upper normal serum level - bilirubin, AST or ALP > 2.5x upper normal serum level, not attributable to AML - heart failure NYHA III/IV - severe obstructive or restrictive ventilation disorder. - Uncontrolled infection. - Severe neurological or psychiatric disorder interfering with ability of giving an informed consent. - Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year. - Known positive for HIV, active HBV, HCV, or Hepatitis A infection. - Bleeding disorder independent of leukemia. - No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation. |
Country | Name | City | State |
---|---|---|---|
Austria | Medizinische Universitäts Graz | Graz | |
Austria | Universitätsklinikum Innsbruck | Innsbruck | |
Austria | Krankenhaus der Barmherzigen Schwestern Linz | Linz | |
Austria | Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. | Linz | |
Austria | Krankenhaus der Elisabethinen Linz | Linz | |
Austria | Salzburger Landeskliniken | Salzburg | |
Austria | Hanuschkrankenhaus Wien | Wien | |
Germany | Klinikum Aschaffenburg-Alzenau | Aschaffenburg | |
Germany | Ubbo-Emmius-Klinik Aurich | Aurich | |
Germany | Helios Klinikum Bad Saarow | Bad Saarow | |
Germany | Charité Berlin - Campus Virchow Klinikum | Berlin | |
Germany | Vivantes Klinikum am Urban | Berlin | |
Germany | Vivantes Klinikum Neukölln | Berlin | |
Germany | Knappschaftskrankenhaus Bochum-Langendreer | Bochum | |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | Städtisches Klinikum Braunschweig gGmbH | Braunschweig | |
Germany | Klinikum Bremen-Mitte | Bremen | |
Germany | Klinikum Darmstadt | Darmstadt | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH | Essen | |
Germany | Klinikum Esslingen | Esslingen | |
Germany | St. Franziskus Hospital | Flensburg | |
Germany | Klinikum Frankfurt Höchst GmbH | Frankfurt-Höchst | |
Germany | Universitätsklinikum Freiburg | Freiburg | |
Germany | Medizinisches Versorgungszentrum Osthessen GmbH | Fulda | |
Germany | Universitätsklinikum Gießen | Gießen | |
Germany | Wilhelm-Anton-Hospital gGmbH Goch | Goch | |
Germany | Universitätsklinikum Göttingen | Göttingen | |
Germany | Asklepios Klinik Altona | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Evangelisches Krankenhaus Hamm gGmbH | Hamm | |
Germany | Klinikum Hanau | Hanau | |
Germany | KRH Klinikum Hannover-Siloah | Hannover | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | SLK-Kliniken GmbH Heilbronn | Heilbronn | |
Germany | Universitätskliniken des Saarlandes | Homburg | |
Germany | Städtisches Klinikum Karlsruhe gGmbH | Karlsruhe | |
Germany | Universitätsklinikum Kiel | Kiel | |
Germany | Caritas-Krankenhaus Lebach | Lebach | |
Germany | Klinikum Lippe-Lemgo | Lemgo | |
Germany | Klinikum Lüdenscheid | Lüdenscheid | |
Germany | Universitätsklinikum der Otto-von Guericke Universität Magdeburg | Magdeburg | |
Germany | Klinikum der Johannes Gutenberg Universität Mainz | Mainz | |
Germany | Johannes Wesling Klinikum Minden | Minden | |
Germany | Klinikum rechts der Isar München | München | |
Germany | Klinikum Schwabing | München | |
Germany | Lukaskrankenhaus GmbH Neuss | Neuss | |
Germany | Ortenau Klinikum Offenburg Gengenbach | Offenburg | |
Germany | Klinikum Oldenburg gGmbH | Oldenburg | |
Germany | Klinikum Passau | Passau | |
Germany | Caritas-Klinik St. Theresia Saarbrücken | Saarbrücken | |
Germany | Stauferklinikum Schwäbisch Gmünd | Schwabisch Gmund | |
Germany | Diakonie-Klinikum Stuttgart | Stuttgart | |
Germany | Klinikum Stuttgart - Katharinenhospital | Stuttgart | |
Germany | Klinikum Traunstein | Traunstein | |
Germany | Krankenhaus der Barmherzigen Brüder | Trier | |
Germany | Universitätsklinikum Tübingen | Tübingen | |
Germany | Universitätsklinikum Ulm | Ulm | |
Germany | Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH | Villingen-Schwenningen | |
Germany | Helios Klinikum Wuppertal | Wuppertal |
Lead Sponsor | Collaborator |
---|---|
University of Ulm |
Austria, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival (OS) | four years | ||
Secondary | Rates of complete remission after induction therapy (CR) | not later than 56 days | ||
Secondary | Cumulative incidences of relapse (CIR) and death in CR (CID) | four years | ||
Secondary | Event-free survival (EFS) | four years | ||
Secondary | Days in hospital during each cycle and during the whole intervention | 6 months | ||
Secondary | Type, frequency, severity, timing and relatedness of AEs and laboratory abnormalities observed during different treatment cycles | 6 months | ||
Secondary | Incidence of infection after induction and consolidation therapy | 6 months | ||
Secondary | Duration of neutropenia and thrombocytopenia after induction and consolidation therapy | 6 months | ||
Secondary | Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al [49] | two years after completion of therapy |
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