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NCT Number: 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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: up to 10 years

Secondary outcomes

  1. Event free survival

    Time frame: up to 10 years

  2. Hematologic remission rate

    Time frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis

  3. Molecular remission rate

    Time frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis

  4. Positron Emission Tomography (PET) based remission evaluation

    Time frame: after induction and consolidation, approximately 6 - 8 weeks from diagnosis

  5. Remission duration

    Time frame: up to 10 years

  6. Relapse rate

    Time frame: up to 10 years

  7. Disease free survival

    Time frame: up to 10 years

  8. Early mortality

    Time frame: during induction therapy with a duration of approximately 6 - 8 weeks

  9. Mortality in Clinical Remission (CR)

    Time frame: up to 10 years

  10. Comorbidities

    Time frame: Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified

  11. Quality of life assessed by Quality of Life Questionnaire (QLQ-C30)

    Time frame: after treatment which is approximately 2.5 years from diagnosis

  12. 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

  13. Toxicities assessed by CTCAE v4.03

    Time frame: during treatment with an approximate duration of 2.5 years from diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

GMALL Study center

CONTACT

[email protected]

Nicola Gökbuget, Dr. med.

CONTACT

[email protected]

+496963016365

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Acronym: GMALLregistry

Important dates

Study start
2009
Primary completion
2030
Study completion
2035
First posted
Aug 19, 2016
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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