OncRef

Clinical Trial: NCT00198991

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

Status:

COMPLETED

Phase:

Phase 4

Lead Sponsor:Goethe University
Information Provided By:Goethe University
Last Update Posted:2022-08-18

Study Overview

Brief Summary

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.

Official Title

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

Conditions

Adult Acute Lymphocytic Leukemia

Intervention / Treatment

  • Drug: Cyclophosphamide
  • Drug: Dexamethasone
  • Drug: Vincristine
  • Drug: Daunorubicin
  • Drug: Asparaginase
  • Drug: Methotrexate
  • Drug: Cytarabine
  • Drug: Mercaptopurine
  • Drug: G-CSF
  • Drug: Vindesine
  • Drug: Etoposide
  • Drug: Prednisolone
  • Drug: Adriamycin
  • Drug: Thioguanine
  • Drug: Teniposide
  • Procedure: CNS irradiation
  • Procedure: Mediastinal Irradiation
  • Procedure: Stem cell transplantation (SCT)
  • Drug: Idarubicin
  • Drug: Fludarabine
  • Drug: Cladribine

Other Study ID Numbers

  • GMALL01

Start Date (Actual)

2003-04

Primary Completion Date (Actual)

2011-06-30

Study Completion Date (Actual)

2013-06-30

Enrollment (Actual)

1883

Study Type

Interventional

Phase

Phase 4