Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03188874
Other study ID # SAL-AML-REG-BIO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2010
Est. completion date September 30, 2030

Study information

Verified date April 2024
Source Technische Universität Dresden
Contact Christoph Röllig, Prof. Dr.
Email christoph.roellig@uniklinikum-dresden.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia. Investigator's sites: 51 sites in Germany. Primary objectives: - Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry. - Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS) - Documentation of treatment strategy


Description:

see brief summary


Recruitment information / eligibility

Status Recruiting
Enrollment 15000
Est. completion date September 30, 2030
Est. primary completion date September 30, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia - Age = 18 years. There is no upper age limit. - Signed written informed consent Exclusion Criteria: - there are no exclusion criteria

Study Design


Locations

Country Name City State
Germany Universitätsklinikum Aachen Aachen Nordrhein-Westfalen
Germany Klinikum Altenburger Land GmbH Altenburg Thüringen
Germany Klinikum Augsburg Augsburg Bayern
Germany Klinikum Mittelbaden Baden-Baden Baden-Württemberg
Germany Sozialstiftung Bamberg Bamberg Bayern
Germany Klinikum Bayreuth GmbH Bayreuth Bayern
Germany Helios Klinikum Berlin-Buch Berlin
Germany Städt. Kliniken Bielefeld gem. GmbH - Klinikum Mitte Bielefeld Nordrhein-Westfalen
Germany Augusta Kranken Anstalt Bochum Bochum Nordrhein-Westfalen
Germany Ev. Diakonie-Krankenhaus gemeinn. GmbH Bremen Bremen
Germany Klinikum Chemnitz gGmbH Chemnitz Sachsen
Germany MVZ Klinikum Coburg GmbH Coburg Bayern
Germany Carl-Thiem-Klinikum Cottbus gGmbH Cottbus Brandenburg
Germany Universitätsklinikum Carl Gustav Carus Dresden Sachsen
Germany Helios Klinikum Duisburg Duisburg Nordrhein-Westfalen
Germany Krankenhaus Düren gGmbH Düren Nordrhein Westfalen
Germany Universitätsklinikum Düsseldorf Düsseldorf Nordrhein-Westfalen
Germany Universitätsklinikum Erlangen Erlangen Bayern
Germany Universitätsklinikum Essen Essen Nordrhein-Westfalen
Germany Universitätsklinikum Frankfurt Frankfurt am Main Hessen
Germany Klinikum Frankfurt (Oder) GmbH Frankfurt an der Oder Brandenburg
Germany Klinikum Fulda / MVZ Osthessen GmbH Fulda Hessen
Germany Klinikum Gütersloh Gütersloh Nordrhein-Westfalen
Germany Krankenhaus Martha-Maria Halle-Dölau Halle (Saale) Sachsen-Anhalt
Germany Universitätsklinikum Halle (Saale) Halle (Saale) Sachsen-Anhalt
Germany St. Barbara-Klinik Hamm GmbH Hamm Nordrhein-Westfalen
Germany Universtitätsklinikum Heidelberg Heidelberg Baden-Württemberg
Germany St. Bernward Krankenhaus Hildesheim Hildesheim Niedersachsen
Germany Universitätsklinikum Jena Jena Thüringen
Germany Städtisches Krankenhaus Kiel GmbH Kiel Schleswig-Holstein
Germany Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein
Germany Stiftungsklinikum Mittelrhein GmbH Koblenz Rheinland-Pfalz
Germany Klinikum St. Georg gGmbH Leipzig Sachsen
Germany Universitätsklinikum Leipzig Leipzig Sachsen
Germany Klinikum Mannheim GmbH Mannheim Baden-Württemberg
Germany Universitätsklinikum Gießen und Marburg Marburg Hessen
Germany Universitätsklinikum Münster Münster Nordrhein-Westfalen
Germany Diakonie Klinikum Dietrich Bonhoeffer Neubrandenburg Mecklenburg-Vorpommern
Germany Klinikum Nürnberg Nürnberg Bayern
Germany Elblandkliniken Stiftung & Co.KG Riesa Sachsen
Germany Klinikum Südstadt Rostock Rostock Mecklenburg-Vorpommern
Germany Agaplesion Diakonieklinikum Rotenburg Rotenburg Niedersachsen
Germany Diakonie-Klinikum Schwäbisch Hall Baden-Württemberg
Germany Diakonie Klinikum GmbH Jung-Stilling-Krankenhaus Siegen Nordrhein-Westfalen
Germany Marien Kliniken, St. Marien-Krankenhaus Siegen Nordhein-Westfalen
Germany Kliniken Sindelfingen-Böblingen gGmbH Sindelfingen Baden-Württemberg
Germany Johanniter-Krankenhaus Genthin-Stendal Stendal Sachsen-Anhalt
Germany Robert-Bosch-Krankenhaus GmbH Stuttgart Baden-Württemberg
Germany Dr. Horst Schmidt Kliniken GmbH Wiesbaden Hessen
Germany Rems-Murr-Klinikum Winnenden Winnenden Baden-Württemberg
Germany Universitätsklinikum Würzburg Würzburg Bayern

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epidemiological parameters Epidemiological parameters 10 years
Primary Relapse free survival (RFS) Relapse free survival 10 years
Primary Time to relapse (TTR), Time to relapse (TTR), 10 years
Primary Overall Survival (OS) Overall Survival (OS) 10 years
Primary cumulative incidence of relapse (CIR) cumulative incidence of relapse (CIR) 10 years
Secondary Complete Remission (CR) Complete Remission yearly follow up 10 years
Secondary Treatment related mortality (TRM) Treatment related mortality yearly follow up 10 years
Secondary Therapy-associated morbidity grade IV toxicities yearly follow up 10 years
Secondary Recording and evaluating the quality of therapy and diagnosis Recording and evaluating the quality of therapy and diagnosis 10 years
Secondary Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors Validation of published prognostic factors at the registry cohort and the search for new possible prognostic factors 10 years
Secondary Recording and describing new forms of therapy and new supportive measures Recording and describing new forms of therapy and new supportive measures 10 years
See also
  Status Clinical Trial Phase
Recruiting NCT04240002 - A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Completed NCT05488613 - Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
Completed NCT02265731 - Study Evaluating Venetoclax in Subjects With Hematological Malignancies Phase 1/Phase 2
Terminated NCT02927938 - Leukemia Stem Cell Detection in Acute Myeloid Leukemia Phase 3
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Completed NCT00071006 - AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04079296 - A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS) Phase 1/Phase 2
Completed NCT04509622 - A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML) Phase 3
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Completed NCT02252107 - 10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1 Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Terminated NCT01463410 - Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler N/A
Completed NCT01242774 - Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML) Phase 1
Terminated NCT02134782 - Yoga Fatigue Study N/A
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Completed NCT03625505 - A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia Phase 1
Active, not recruiting NCT04266795 - A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy Phase 2
Recruiting NCT04446741 - Molecular Diagnostic Platform for AML