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

Information source: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adult Acute Lymphocytic Leukemia

Intervention: 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)

Phase: Phase 4

Status: Completed

Sponsored by: Johann Wolfgang Goethe University Hospitals

Official(s) and/or principal investigator(s):
Dieter Hoelzer, MD,PhD, Study Chair, Affiliation: University Hospital Frankfurt, Medical Dept. II


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Remission rate,Remission duration,Disease free survival,Overall survival

Secondary outcome: Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD


Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

University Hospital, Medical Dept. II, Frankfurt 60590, Germany
Additional Information

Starting date: October 1999
Last updated: May 16, 2008

Page last updated: August 23, 2015

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