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Completed

NCT Number: NCT00199056

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

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. A MRD based risk stratification and treatment decision is developed.

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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, 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, T)
  • Age 15-65 yrs (*55-65 years if biologically younger according to general condition)

Exclusion criteria

  • Severe comorbidity
  • Cytostatic pre-treatment
  • Pregnancy
  • Missing written informed consent

Treatment and study plan

Dexamethasone / Prednisolone

Drug

Cyclophosphamide

Drug

methotrexate

Drug

Vincristine / Vindesine

Drug

Daunorubicin

Drug

asparaginase

Drug

G-CSF

Drug

Cytarabine

Drug

6-Mercaptopurine

Drug

VP16

Drug

Adriamycin

Drug

thioguanine

Drug

VM26

Drug

Idarubicin

Drug

Fludarabine

Drug

ifosfamide

Drug

CNS irradiation

Procedure

Mediastinal irradiation (if residual tumor)

Procedure

stem cell transplantation

Procedure

Primary outcomes

  1. Remission rate,Remission duration,Disease free survival,Overall survival

Secondary outcomes

  1. Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)

Important dates

Study start
1999
Primary completion
2003
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Mar 20, 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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