Collaborator:
AbbVie, University Hospital Leipzig, Hematology Diagnostics Laboratory, University of Leipzig, Clinical Trial Centre (ZKS),
Studienleiter
Klaus Metzeler, Prof. Dr. Principal Investigator Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Kontakt
Klaus Metzeler, Prof. Dr. Kontakt: Phone: +49 341 97-13050 E-Mail: Klaus.Metzeler@medizin.uni-leipzig.de» Kontaktdaten anzeigen Uwe Platzbecker, Prof. Dr. Kontakt: Phone: +49 341 97-13050 E-Mail: uwe.platzbecker@medizin.uni-leipzig.de» Kontaktdaten anzeigen
Studienlocations (3 von 10)
Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation 13125 Berlin (Berlin) GermanyRekrutierend» Google-Maps Ansprechpartner: Pearl van Heteren, Dr. E-Mail: Pearl.vanHeteren@helios-gesundheit.de» Ansprechpartner anzeigenKlinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill 09116 Chemnitz (Sachsen) GermanyAktiv, nicht rekrutierend» Google-MapsCarl-Thiem-Klinikum Cottbus gGmbH 03048 Cottbus (Brandenburg) GermanyRekrutierend» Google-Maps Ansprechpartner: Martin Schmidt-Hieber, PD Dr. E-Mail: m.schmidt_hieber@ctk.de» Ansprechpartner anzeigen
Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie 01307 Dresden (Sachsen) GermanyAktiv, nicht rekrutierend» Google-MapsUniversitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie 69120 Heidelberg (Baden-Württemberg) GermanyAktiv, nicht rekrutierend» Google-MapsUniversitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie Leipzig (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Klaus Metzeler, Prof. Dr. E-Mail: Klaus.Metzeler@medizin.uni-leipzig.de
E-Mail: haematologie.studieneinheit@medizin.uni-leipzig.de» Ansprechpartner anzeigenKliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie 41063 Mönchengladbach (Nordrhein-Westfalen) GermanyAktiv, nicht rekrutierend» Google-MapsRotkreuzklinikum München, III. Medizinische Abteilung 80364 München (Bayern) GermanyRekrutierend» Google-Maps Ansprechpartner: Alexander Höllein, Prof. E-Mail: alexander.hoellein@swmbrk.de» Ansprechpartner anzeigenKlinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill 81675 München (Bayern) GermanyAktiv, nicht rekrutierend» Google-MapsKliniken Sindelfingen,Medizinische Klinik I 71065 Sindelfingen (Baden-Württemberg) GermanyAktiv, nicht rekrutierend» Google-Maps
1. The primary outcome measure is the response rate defined as the rate of CR/CRi after up to 6 cycles of therapy (best response). (Time Frame - best response after up to 6 cycles (each cycle is 28 days)): Bone marrow assessments will be performed at least at screening, at the end of cycle 1, after cycle 4 and after cycle 6 resp. end of treatment (EOT). Criteria for disease status / response assessment follow the ELN-2022 recommendations .
Secondary outcome:
1. Rate of CR or CRi by the Initiation of Cycle 2 (Time Frame - At the end of Cycle 1 (each cycle is 28 days)): Rate of CR or CRi by the Initiation of Cycle 2. Criteria for disease status / response assessment follow the European LeukemiaNet (ELN) - 2022 recommendations.
2. Rate of CR with partial hematologic recovery (CRh) after up to 6 cycles of therapy (Time Frame - after up to 6 cycles (each cycle is 28 days)): Rate of CR with partial hematologic recovery (CRh) after up to 6 cycles of therapy. Criteria for disease status / response assessment follow the ELN-2022 recommendations.
3. Time from initiation of treatment (C1D1) until achievement of CR or CRi (Time Frame - from start of treatment (C1D1) until up to 6 cycles (each cycle is 28 days)): Time from initiation of treatment (C1D1) until achievement of CR or CRi. Criteria for disease status / response assessment follow the ELN-2022 recommendations.
4. Objective response rate (Time Frame - at EOT, after up to 6 cycles therapy (each cycle is 28 days)): Objective response rate (CR, CRh, CRi, MLFS). Criteria for disease status / response assessment follow the ELN-2022 recommendations.
5. Event free survival (EFS) (Time Frame - From start of treatment to the date of relapse from CR or CRi, treatment failure (i.e., no CR or CRi after up to 6 cycles (each cycle is 28 days) of therapy or disease progression requiring treatment discontinuation), or death from any cause.): Event free survival (EFS), defined as the number of days from start of treatment to the date of relapse from CR or CRi, treatment failure (i.e., no CR or CRi after 6 cycles (each cycle is 28 days) of therapy or disease progression requiring treatment discontinuation), or death from any cause.
6. Overall survival (OS) (Time Frame - From start of treatment to date of death from any cause. OS will be assessed until 3 months after end of treatment of the last patient on study.): Overall survival (OS), defined as the number of days from start of treatment to death from any cause.
After EOT, patients will be further followed up for survival until the end of the trial is reached (= last patient out, i.e. when the last surviving patient has reached the 3-month follow-up visit after EOT). Therefore, the duration of follow-up can differ between patients but is at least 3 months after EOT.
7. Descriptive assessment of measurable residual disease (MRD) levels on study treatment, determined by quantitative PCR or targeted next-generation sequencing (Time Frame - From Screening until EOT (after up to 6 cycles (each cycle is 28 days))): Determined by quantitative PCR or targeted next-generation sequencing. Molecular profiling and MRD assessment of all patients will be carried out centrally (Hämatologisches Diagnostiklabor, Universitätsklinikum Leipzig), at least at screening, at the end of cycle 1, after cycle 4 and after cycle 6 resp. end of treatment (EOT).
8. Time to treatment discontinuation (Time Frame - From start of treatment to day of treatment discontinuation (within up to 6 cycles (each cycle is 28 days))): Time to treatment discontinuation, defined as the number of days from start of treatment to premature stop of treatment. The stop date is the date the first cycle that was not given should have started as scheduled. This endpoint will be analyzed with death and progression or relapse as competing risk.
9. Rate of patients with at least one treatment interruption (Time Frame - From start of treatment until EOT (after up to 6 cycles (each cycle is 28 days))): Rate of patients with at least one treatment interruption, i.e. a delay of the next cycle, and duration of treatment interruptions.
10. Delay of subsequent cycles, dose reductions or shortening/interruption of study drug administration (Time Frame - From start of treatment until EOT (after up to 6 cycles (each cycle is 28 days))): Delay of subsequent cycles, dose reductions or shortening/interruption of study drug administration
11. Duration of patient hospitalization (Time Frame - From start of treatment until EOT (after up to 6 cycles (each cycle is 28 days))): Duration of patient hospitalization, defined as days in hospital from start of treatment until EOT.
12. Quality of life (QoL) (Time Frame - From Screening until EOT (after up to 6 cycles (each cycle is 28 days))): The established cancer-specific Core Quality of Life questionnaire QLQ-C30 from the EORTC (European Organisation for Research) will be used for QoL measurement, at screening and at the beginning of each cycle and at EOT.
