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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

Page last updated: August 23, 2015

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