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German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00198978
Recruitment Status : Unknown
Verified June 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

Study Description
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Brief Summary:
The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia Drug: Cyclophosphamide Drug: Dexamethasone / Prednisolone Drug: Cytarabine Drug: Idarubicin Drug: Granulocyte-Colony-Stimulating Factor Drug: Mercaptopurine Drug: Methotrexate Drug: Rituximab Drug: HDARAC Drug: Vincristine Drug: Depocyte Drug: Asparaginase Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)
Study Start Date : January 2003
Estimated Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Remission rate (cytologic, Remission rate (molecular), Survival time, Duration of Remission, Toxicity (CTC, Treatment realization

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
  • Age > 55 yrs (no upper age limit)
  • Written informed consent

Exclusion Criteria:

  • Severe leukemia associated complications, not controllable before therapy onset e.g.
  • life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
  • Severe comorbidity e.g.
  • decompensated renal failure if not caused by leukemia with Creatinine > 2x ULN
  • heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
  • hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin > 1,5 x ULN and/or ASA, ALA, AP > 2,5 ULN
  • decompensated metabolic disturbances (e.g. not controllable diabetes)
  • severe obstructive or restrictive pulmonary disease with hypoxaemia
  • Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
  • Active second neoplasia
  • HIV infection
  • Severely reduced general condition
  • Cytostatic pre-treatment of ALL
  • Chemotherapy treatment of any other malignancy during the last 5 years
  • Participation in other clinical trials interfering with the study therapy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198978


Contacts
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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
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Germany
University of Frankfurt, Medical Dept. II Recruiting
Frankfurt, Germany, 60590
Contact: Dieter Hoelzer, MD,PhD    ++49(0)6963015194    hoelzer@em.uni-frankfurt.de   
Contact: Nicola Goekbuget, MD    ++49(0)6963016365    goekbuget@em.uni-frankfurt.de   
Principal Investigator: Dieter Hoelzer, MD,PhD         
Sub-Investigator: Nicola Goekbuget, MD         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Study Chair: Dieter Hoelzer, MD,PhD University of Frankfurt, Medical Dept. II
More Information
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Additional Information:
European Leukemia Trial Registry  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00198978     History of Changes
Other Study ID Numbers: GMALL02
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008
Keywords provided by Johann Wolfgang Goethe University Hospital:
ALL
Treatment
Elderly
De novo
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisolone
Cyclophosphamide
Methotrexate
Vincristine
 Idarubicin
Asparaginase
Mercaptopurine
Sargramostim
Lenograstim
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal