GMALL Registry Study on Acute Lymphoblastic Leukemia (ALL): Prospective Collection of Data on Diagnosis, Treatment, Course of the Disease, and Biological Samples in Adult ALL Patients

Acute lymphoblastic leukemia (ALL) is a malignant disease of the lymphatic system characterized by the uncontrolled production of blasts in the bone marrow and blood. Blasts are an immature and, in this case, malignant form of white blood cells, which are part of the immune system. The overproduction of blasts disrupts normal blood formation and immune defense. In ALL, other organs or the central nervous system may also be affected. Consequently, fatigue, anemia, blood clotting disorders, fever, and an increased susceptibility to infections may occur. More than half of patients have swollen lymph nodes and an enlarged spleen. The exact cause of ALL is not fully understood, but genetic mutations and environmental factors play a role. The standard treatment for ALL consists of intensive chemotherapy and, depending on the response and underlying risk factors, a stem cell transplant. Complete eradication of the disease is essential for survival, so treatment is usually carried out according to highly standardized treatment regimens (protocols); in Germany, the GMALL protocol is the most commonly used for adults.

The GMALL registry study aims to collect comprehensive data on the diagnosis, treatment, and course of ALL and related diseases in adults. These diseases include: NK-cell lymphoma, NK-cell leukemia, mixed-phenotype acute leukemia (MPAL), non-Hodgkin lymphomas (including Burkitt lymphoma, B-cell lymphoma, lymphoblastic lymphoma of B-cells or T-cells, and anaplastic large-cell lymphoma)—provided they are treated according to an ALL-like protocol. This long-term, systematic data collection is intended to help improve treatment options and enhance patients’ quality of life. The study also includes the collection of biomaterials (e.g., blood, bone marrow) to support future research projects. The data and samples will be stored in pseudonymized form and may be used by scientists and physicians for ALL-related research projects. The study is observational, which means that no medications or new forms of therapy will be tested. The primary endpoint of the observational study is 10-year overall survival.

Women and men aged 18 and older who have ALL or a related form of ALL and who have been or are being treated according to the GMALL treatment protocols or those for specific subtypes (e.g., B-ALL) are eligible to participate in the study.