Clinical trial NCT02872987: 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
Official title: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Leukemia
Non-Hodgkin's Lymphoma
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute Lymphoblastic Leukemia or seleted NHL

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Event free survival
timeFrame: up to 10 years
measure: Hematologic remission rate
timeFrame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis
measure: Molecular remission rate
timeFrame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis
measure: Positron Emission Tomography (PET) based remission evaluation
timeFrame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis
measure: Remission duration
timeFrame: up to 10 years
measure: Relapse rate
timeFrame: up to 10 years
measure: Disease free survival
timeFrame: up to 10 years
measure: Early mortality
timeFrame: during induction therapy with a duration of approximately 6 - 8 weeks
measure: Mortality in Clinical Remission (CR)
timeFrame: up to 10 years
measure: Comorbidities
timeFrame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
measure: Quality of life assessed by Quality of Life Questionnaire (QLQ-C30)
timeFrame: after treatment which is approximately 2.5 years from diagnosis
measure: Eastern Cooperative Oncology Group (ECOG) status
timeFrame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified
measure: Toxicities assessed by CTCAE v4.03
timeFrame: during treatment with an approximate duration of 2.5 years from diagnosis
Other outcomes:
Locations:
city: Frankfurt (Main)
country: Germany
facility: University Hospital of Frankfurt (Main)
state: Hessen
city: Aachen
country: Germany
facility: Uniklinik Aachen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Vivantes-Klinikum am Urban
city: Bonn
country: Germany
facility: Universität Bonn
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Klinikum Carl-Gustav-Carus
city: Düsseldorf
country: Germany
facility: Universitätsklinik Düsseldorf
city: Erlangen
country: Germany
facility: Universität Erlangen
city: Essen
country: Germany
facility: Evang. Krankenhaus Essen-Werden
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum
city: Gießen
country: Germany
facility: Klinik der Justus--Universität
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität
city: Göttingen
country: Germany
facility: Universitätsklinikum
city: Hagen
country: Germany
facility: Katholisches Krankenhaus Hagen gGmbH
city: Halle/Saale
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
city: Hamburg
country: Germany
facility: Uiversitätsklinikum Hamburg-Eppendorf
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm gGmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Karlsruhe
country: Germany
facility: Städt. Klinikum Karlsruhe
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Köln
country: Germany
facility: Universitätsklinik Köln
city: Mainz
country: Germany
facility: Universitätskliniken Mainz
city: Mannheim
country: Germany
facility: Klinikum Mannheim
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: München
country: Germany
facility: Klinikum München-Schwabing
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
city: München
country: Germany
facility: Krankenhaus München-Harlaching
city: München
country: Germany
facility: Universitätsklinikum Großhadern
city: Münster
country: Germany
facility: Universitätsklinik
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock
city: Schwerin
country: Germany
facility: Helios Klinikum Schwerin
city: Schwäbisch-Hall
country: Germany
facility: Diakonie-Krankenhaus
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Ulm
country: Germany
facility: Medizinische Universitätsklinik
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
Study officials:
affiliation: University Hospital of Frankfurt (Main)
name: Nicola Gökbuget, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: