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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Lymphoblastic Leukemia, Leukemia, Non-Hodgkin's Lymphoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B-ALL/NHL<br> | |
| ALL/ Lymphoblastic Lymphoma (LBL)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival |  | up to 10 years | 
| Hematologic remission rate |  | after induction and consolidation, approximately 6 - 8 weeks from diagnosis | 
| Molecular 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 | 
| Remission duration |  | up to 10 years | 
| Relapse rate |  | up to 10 years | 
| Disease free survival |  | up to 10 years | 
| Early mortality |  | during induction therapy with a duration of approximately 6 - 8 weeks | 
| Mortality in Clinical Remission (CR) |  | up to 10 years | 
| Comorbidities |  | 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) |  | after treatment which is approximately 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 | 
| Toxicities assessed by CTCAE v4.03 |  | during treatment with an approximate duration of 2.5 years from diagnosis |