GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial

Leukemia Clinical Trial

— GMALLregistry  

Official title:

Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02872987
• Other study ID #: GMALL_Registry
• Status: Recruiting
• Start date: February 2009
• Est. completion date: December 2030

Study information

• Verified date: August 2022
• Source: Goethe University
• Contact: Nicola Gökbuget, Dr. med.
• Phone: +496963016365
• Email: goekbuget[@]em.uni-frankfurt.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols
• Other Types of Leukemia (NK Cell Lymphoma/Leukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols
• Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols
• Age minimum 18 yrs

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Non-Hodgkin's Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Germany	Uniklinik Aachen	Aachen
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Vivantes-Klinikum am Urban	Berlin
Germany	Universität Bonn	Bonn
Germany	Klinikum Bremen-Mitte gGmbH	Bremen
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Klinikum Carl-Gustav-Carus	Dresden
Germany	Universitätsklinik Düsseldorf	Düsseldorf
Germany	Universität Erlangen	Erlangen
Germany	Evang. Krankenhaus Essen-Werden	Essen
Germany	Universitätsklinikum Essen	Essen
Germany	University Hospital of Frankfurt (Main)	Frankfurt (Main)	Hessen
Germany	Universitätsklinikum	Freiburg
Germany	Klinik der Justus--Universität	Gießen
Germany	Universitätsklinikum	Göttingen
Germany	Ernst-Moritz-Arndt-Universität	Greifswald
Germany	Katholisches Krankenhaus Hagen gGmbH	Hagen
Germany	Martin-Luther-Universität Halle-Wittenberg	Halle/Saale
Germany	Uiversitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Evangelisches Krankenhaus Hamm gGmbH	Hamm
Germany	Medizinische Hochschule	Hannover
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Universitätsklinikum Jena	Jena
Germany	Städt. Klinikum Karlsruhe	Karlsruhe
Germany	Klinikum Kassel GmbH	Kassel
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Universitätsklinik Köln	Köln
Germany	Universitätskliniken Mainz	Mainz
Germany	Klinikum Mannheim	Mannheim
Germany	Universitätsklinikum Gießen und Marburg GmbH	Marburg
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Klinikum München-Schwabing	München
Germany	Klinikum Rechts der Isar der TU München	München
Germany	Krankenhaus München-Harlaching	München
Germany	Universitätsklinikum Großhadern	München
Germany	Universitätsklinik	Münster
Germany	Klinikum Nürnberg Nord	Nürnberg
Germany	Klinikum Oldenburg	Oldenburg
Germany	Klinikum Ernst von Bergmann	Potsdam
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Universitätsklinikum Rostock	Rostock
Germany	Diakonie-Krankenhaus	Schwäbisch-Hall
Germany	Helios Klinikum Schwerin	Schwerin
Germany	Diakonie-Klinikum Stuttgart	Stuttgart
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Germany	Universitätsklinik Tübingen	Tübingen
Germany	Medizinische Universitätsklinik	Ulm
Germany	Universitätsklinikum Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		up to 10 years
Secondary	Event free survival		up to 10 years
Secondary	Hematologic remission rate		after induction and consolidation, approximately 6 - 8 weeks from diagnosis
Secondary	Molecular remission rate		after induction and consolidation, approximately 6 - 8 weeks from diagnosis
Secondary	Positron Emission Tomography (PET) based remission evaluation		after induction and consolidation, approximately 6 - 8 weeks from diagnosis
Secondary	Remission duration		up to 10 years
Secondary	Relapse rate		up to 10 years
Secondary	Disease free survival		up to 10 years
Secondary	Early mortality		during induction therapy with a duration of approximately 6 - 8 weeks
Secondary	Mortality in Clinical Remission (CR)		up to 10 years
Secondary	Comorbidities		Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
Secondary	Quality of life assessed by Quality of Life Questionnaire (QLQ-C30)		after treatment which is approximately 2.5 years from diagnosis
Secondary	Eastern Cooperative Oncology Group (ECOG) status		Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
Secondary	Toxicities assessed by CTCAE v4.03		during treatment with an approximate duration of 2.5 years from diagnosis