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

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00199056

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

Condition	Intervention	Phase
Adult Acute Lymphocytic Leukemia	Drug: 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 Procedure: CNS irradiation Procedure: Mediastinal irradiation (if residual tumor) Procedure: stem cell transplantation	Phase IV

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

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide 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 Teniposide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)

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:	225
Study Start Date:	October 1999

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, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199056

Locations

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

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital 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:	GMALL10
Study First Received:	September 12, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00199056
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

ALL
Treatment
De Novo
Adult

Study placed in the following topic categories:

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

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