German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003) - Full Text View

Sponsors and Collaborators:	Johann Wolfgang Goethe University Hospitals Deutsche Krebshilfe e.V., Bonn (Germany) Bundesministerium für Bildung und Forschung
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00198991

Purpose

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.

Condition	Intervention	Phase
Adult Acute Lymphocytic Leukemia	Drug: 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 Procedure: CNS irradiation Procedure: Mediastinal Irradiation Procedure: Stem cell transplantation Drug: Idarubicin Drug: Fludarabine Drug: Cladribine	Phase IV

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Cytarabine Cytarabine hydrochloride Etoposide Idarubicin Idarubicin hydrochloride Mercaptopurine 6-Mercaptopurine L-Asparaginase Daunorubicin hydrochloride Daunorubicin Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Vincristine sulfate Vincristine Fludarabine Fludarabine monophosphate Granulocyte colony-stimulating factor Etoposide phosphate Thioguanine Vindesine Cladribine Teniposide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	1250
Study Start Date:	April 2003
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198991

Contacts

Contact: Dieter Hoelzer, MD, PhD	++49 (0)69 6301 5194	hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD	++49(0)69 6301 6365	goekbuget@em.uni-frankfurt.de

Locations

Germany
University of Frankfurt, Medical Dept. II	Recruiting
Frankfurt, Germany, 60590
Contact: Dieter Hoelzer, MD,PhD ++49(0)69 6301 5194 hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD ++49(0)69 6301 6365 goekbuget@em.uni-frankfurt.de
Principal Investigator: Dieter Hoelzer, MD,PhD
Sub-Investigator: Nicola Goekbuget, MD

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Deutsche Krebshilfe e.V., Bonn (Germany)

Bundesministerium für Bildung und Forschung

Investigators

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital of Frankfurt, Medical Dept. II

More Information

European Leukemia Trial Registry This link exits the ClinicalTrials.gov site

German Leukemia Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	GMALL01
Study First Received:	September 12, 2005
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00198991
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

ALL
Treatment
de novo
Minimal residual disease
Adult

Study placed in the following topic categories:

Cladribine
Neoplasm, Residual
Dexamethasone
Daunorubicin
Leukemia, Lymphoid
Methylprednisolone
Vindesine
Prednisolone acetate
Cyclophosphamide
6-Mercaptopurine
Etoposide phosphate
Acute lymphoblastic leukemia, adult
Leukemia
Methotrexate
Lymphoma

Etoposide
Dexamethasone acetate
Cytarabine
Methylprednisolone Hemisuccinate
Asparaginase
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Thioguanine
Methylprednisolone acetate
Vincristine
Fludarabine monophosphate
Doxorubicin
Folic Acid
Teniposide
Lymphatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Abortifacient Agents

Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on January 15, 2009