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Completed

NCT Number: NCT00198991

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

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Key information

Conditions

Adult Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Frankfurt, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
  • Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
  • Written informed consent

Exclusion criteria

  • Severe comorbidity or leukemia associated complications
  • Late relapse of pediatric ALL or ALL as second malignancy
  • Cytostatic pre-treatment
  • Pregnancy
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Participation in other clinical trials interfering with the study therapy

Treatment and study plan

Cyclophosphamide

Drug

Cytostatic drug

Dexamethasone

Drug

Antileukemic drug

Vincristine

Drug

Cytostatic drug

Daunorubicin

Drug

Cytostatic drug

asparaginase

Drug

Cytostatic drug

Other names: Pegylated Asparaginase

methotrexate

Drug

Cytostatic drug

Cytarabine

Drug

Cytostatic drug

mercaptopurine

Drug

Cytostatic drug

G-CSF

Drug

Growth factor

Vindesine

Drug

Cytostatic drug

etoposide

Drug

Cytostatic drug

Other names: Etoposide Phosphate

Prednisolone

Drug

Antileukemic drug

Adriamycin

Drug

Cytostatic drug

thioguanine

Drug

Cytostatic drug

Teniposide

Drug

Cytostatic drug

CNS irradiation

Procedure

Cytostatic drug

Mediastinal irradiation

Procedure

Irradiation

Stem cell transplantation (SCT)

Procedure

Stem cell transplantation

Idarubicin

Drug

Cytostatic drug

Fludarabine

Drug

Cytostatic drug

cladribine

Drug

Cytostatic drug

Primary outcomes

  1. Remission rate

    Time frame: day 46

    Rate of patients with complete remission

  2. Remission duration

    Time frame: up to 10 years

    Rate and probability of patients with ongoing remission after prior achievement of remission

  3. Disease free survival

    Time frame: up to 10 years

    Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy

  4. Overall survival

    Time frame: up to 10 years

    Rate and probability of patients remaining alive

Secondary outcomes

  1. Realisation of Stem cell transplantation (SCT)

    Time frame: up to 10 years

    Rate of patients receiving an SCT

  2. Toxicity according to WHO/CTCAE

    Time frame: after each cycle up to 2.5 years

    Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)

  3. Response assessment based on MRD

    Time frame: up to 5 years

    Rate of MRD response after specific cycles

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • German Federal Ministry of Education and Research

Registry information

Official study title

German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)

Important dates

Study start
2003
Primary completion
2011
Study completion
2013
First posted
Sep 20, 2005
Registry last updated
Aug 18, 2022

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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