Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Leukemia, Non-Hodgkin's Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial
Overview
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.
Primary outcome measures
- Overall survival [Time frame: up to 10 years]
Secondary outcome measures (12)
- Event free survival [Time frame: up to 10 years]
- Hematologic remission rate [Time frame: 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]
- Positron Emission Tomography (PET) based remission evaluation [Time frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis]
- Remission duration [Time frame: up to 10 years]
- Relapse rate [Time frame: up to 10 years]
- Disease free survival [Time frame: up to 10 years]
- Early mortality [Time frame: during induction therapy with a duration of approximately 6 - 8 weeks]
- Mortality in Clinical Remission (CR) [Time frame: 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]
- Quality of life assessed by Quality of Life Questionnaire (QLQ-C30) [Time frame: 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 142 centers
- University Hospital of Frankfurt (Main) — Frankfurt am Main
- Universitätsklinikum Aachen — Aachen
- Klinikum Altenburger Land — Altenburg
- Kreiskliniken Altötting — Altötting
- Klinikum Aschaffenburg — Aschaffenburg
- Klinikum Augsburg — Augsburg
- Helios Klinikum Bad Saarow — Bad Saarow
- Sozialstiftung Bamberg — Bamberg
- … and 134 more centers
Austria · 5 centers
- Universitätsklinikum Graz — Graz
- LKH-Hochsteiermark Leoben — Leoben
- Ordensklinikum Linz Elisabethinen — Linz
- Universitätsklinikum St. Pölten — Sankt Pölten
- Hanusch-Krankenhaus Wien — Vienna
Identifiers
NCT: NCT02872987 · GMALL_Registry