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 (GMALLregistry)

August 16, 2022 updated by: Nicola Goekbuget, Goethe University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany
        • Recruiting
        • Uniklinik Aachen
      • Berlin, Germany
        • Recruiting
        • Charite Universitatsmedizin Berlin
      • Berlin, Germany
        • Recruiting
        • Vivantes Klinikum Neukölln
      • Berlin, Germany
        • Not yet recruiting
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany
        • Not yet recruiting
        • Vivantes-Klinikum Am Urban
      • Bonn, Germany
        • Not yet recruiting
        • Universitat Bonn
      • Bremen, Germany
        • Recruiting
        • Klinikum Bremen-Mitte gGmbH
      • Chemnitz, Germany
        • Not yet recruiting
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany
        • Recruiting
        • Klinikum Carl-Gustav-Carus
      • Düsseldorf, Germany
        • Not yet recruiting
        • Universitätsklinik Düsseldorf
      • Erlangen, Germany
        • Not yet recruiting
        • Universität Erlangen
      • Essen, Germany
        • Recruiting
        • Universitätsklinikum Essen
      • Essen, Germany
        • Recruiting
        • Evang. Krankenhaus Essen-Werden
      • Freiburg, Germany
        • Recruiting
        • Universitätsklinikum
      • Gießen, Germany
        • Not yet recruiting
        • Klinik der Justus--Universität
      • Greifswald, Germany
        • Not yet recruiting
        • Ernst-Moritz-Arndt-Universität
      • Göttingen, Germany
        • Not yet recruiting
        • Universitätsklinikum
      • Hagen, Germany
        • Not yet recruiting
        • Katholisches Krankenhaus Hagen gGmbH
      • Halle/Saale, Germany
        • Not yet recruiting
        • Martin-Luther-Universität Halle-Wittenberg
      • Hamburg, Germany
        • Recruiting
        • Uiversitätsklinikum Hamburg-Eppendorf
      • Hamm, Germany
        • Recruiting
        • Evangelisches Krankenhaus Hamm gGmbH
      • Hannover, Germany
        • Not yet recruiting
        • Medizinische Hochschule
      • Homburg/Saar, Germany
        • Not yet recruiting
        • Universitätsklinikum des Saarlandes
      • Jena, Germany
        • Recruiting
        • Universitätsklinikum Jena
      • Karlsruhe, Germany
        • Recruiting
        • Städt. Klinikum Karlsruhe
      • Kassel, Germany
        • Not yet recruiting
        • Klinikum Kassel GmbH
      • Kiel, Germany
        • Not yet recruiting
        • Universitatsklinikum Schleswig-Holstein
      • Köln, Germany
        • Not yet recruiting
        • Universitätsklinik Köln
      • Mainz, Germany
        • Not yet recruiting
        • Universitätskliniken Mainz
      • Mannheim, Germany
        • Not yet recruiting
        • Klinikum Mannheim
      • Marburg, Germany
        • Not yet recruiting
        • Universitätsklinikum Giessen und Marburg GmbH
      • Minden, Germany
        • Recruiting
        • Johannes Wesling Klinikum Minden
      • München, Germany
        • Not yet recruiting
        • Klinikum München-Schwabing
      • München, Germany
        • Not yet recruiting
        • Klinikum rechts der Isar der TU Munchen
      • München, Germany
        • Not yet recruiting
        • Krankenhaus München-Harlaching
      • München, Germany
        • Recruiting
        • Universitätsklinikum Großhadern
      • Münster, Germany
        • Not yet recruiting
        • Universitätsklinik
      • Nürnberg, Germany
        • Recruiting
        • Klinikum Nurnberg Nord
      • Oldenburg, Germany
        • Not yet recruiting
        • Klinikum Oldenburg
      • Potsdam, Germany
        • Recruiting
        • Klinikum Ernst von Bergmann
      • Regensburg, Germany
        • Recruiting
        • Universitatsklinikum Regensburg
      • Rostock, Germany
        • Not yet recruiting
        • Universitätsklinikum Rostock
      • Schwerin, Germany
        • Recruiting
        • Helios Klinikum Schwerin
      • Schwäbisch-Hall, Germany
        • Recruiting
        • Diakonie-Krankenhaus
      • Stuttgart, Germany
        • Recruiting
        • Robert-Bosch-Krankenhaus
      • Stuttgart, Germany
        • Not yet recruiting
        • Diakonie-Klinikum Stuttgart
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder
      • Tübingen, Germany
        • Not yet recruiting
        • Universitatsklinik Tubingen
      • Ulm, Germany
        • Recruiting
        • Medizinische Universitätsklinik
      • Würzburg, Germany
        • Not yet recruiting
        • Universitatsklinikum Wurzburg
    • Hessen
      • Frankfurt (Main), Hessen, Germany, 60590
        • Recruiting
        • University Hospital of Frankfurt (Main)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute Lymphoblastic Leukemia or seleted NHL

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
B-ALL/NHL
ALL/ Lymphoblastic Lymphoma (LBL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: up to 10 years
up to 10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goethe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

December 1, 2030

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (ESTIMATE)

August 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMALL_Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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