German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)
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: Cyclophosphamide (Drug); Dexamethasone (Drug); Vincristine (Drug); daunorubicin (Drug); Asparaginase (Drug); Methotrexate (Drug); Cytarabine (Drug); Mercaptopurine (Drug); G-CSF (Drug); Vindesine (Drug); VP16 (Drug); Prednisolone (Drug); Adriamycin (Drug); Thioguanine (Drug); VM26 (Drug); CNS irradiation (Procedure); Mediastinal Irradiation (Procedure); Stem cell transplantation (Procedure); Idarubicin (Drug); Fludarabine (Drug); Cladribine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Johann Wolfgang Goethe University Hospitals Official(s) and/or principal investigator(s): Dieter Hoelzer, MD,PhD, Study Chair, Affiliation: University Hospital of Frankfurt, Medical Dept. II
Overall contact: Dieter Hoelzer, MD, PhD, Phone: ++49 (0)69 6301 5194, Email: hoelzer@em.uni-frankfurt.de
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.
Clinical Details
Official title: German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
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
Eligibility
Minimum age: 15 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dieter Hoelzer, MD, PhD, Phone: ++49 (0)69 6301 5194, Email: hoelzer@em.uni-frankfurt.de
University of Frankfurt, Medical Dept. II, Frankfurt 60590, Germany; Recruiting Dieter Hoelzer, MD,PhD, Phone: ++49(0)69 6301 5194, Email: hoelzer@em.uni-frankfurt.de Nicola Goekbuget, MD, Phone: ++49(0)69 6301 6365, Email: goekbuget@em.uni-frankfurt.de Dieter Hoelzer, MD,PhD, Principal Investigator Nicola Goekbuget, MD, Sub-Investigator
Additional Information
Starting date: April 2003
Last updated: May 29, 2008
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