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Completed

NCT Number: NCT00199069

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

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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 Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Medical Dept. II

Frankfurt, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute Lymphocytic Leukemia
  • Age 15 - 65 years

Exclusion criteria

  • Serious secondary diseases which may compromise intensified chemotherapeutical treatment
  • Serious psychiatric diseases, which may compromise compliance with therapy
  • HIV-1 or HIV-2 Infection
  • Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
  • Patients without central diagnosis who cannot be allocated to a risk group

Treatment and study plan

asparaginase

Drug

Vincristine

Drug

Daunorubicin, Adriamycin

Drug

Cyclophosphamide

Drug

ifosfamide

Drug

Cytarabine

Drug

Mitoxantrone

Drug

methotrexate

Drug

6-Mercaptopurine

Drug

6-thioguanine

Drug

VM26

Drug

Dexamethasone / Prednisolone

Drug

CNS irradiation

Procedure

Mediastinal irradiation

Procedure

stem cell transplantation

Procedure

Primary outcomes

  1. remission rate, disease free survival, overall survival

Secondary outcomes

  1. death in induction, toxicity, time and dose compliance

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Official study title

Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)

Important dates

Study start
1993
Primary completion
1999
Study completion
2001
First posted
Sep 20, 2005
Registry last updated
Mar 17, 2023

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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