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

Recruiting

• Conditions: Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma; Leukemia

• Registration Number: NCT02872987
• Lead Sponsor: Goethe University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 10 years

Secondary Outcome Measures

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

Trial Locations

Locations (50)

University Hospital of Frankfurt (Main); 🇩🇪 Frankfurt (Main), Hessen, 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

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