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Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00199095
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy

Condition or disease Intervention/treatment Phase
Adult Acute Lymphocytic Leukemia Drug: Adriamycin Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Idarubicin Drug: Ifosfamide Drug: Methotrexate Drug: Mercaptopurine Drug: VM26 Drug: Vincristine Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
Study Start Date : February 1997





Primary Outcome Measures :
  1. Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
  • age > 65 years
  • written informed consent
  • Karnofsky > 50% (if not mainly caused by leukemia)
  • laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN

Exclusion Criteria:

  • severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
  • severe psychiatric illness or other circumstances which may compromise cooperation
  • active second neoplasia
  • clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy

Information from the National Library of Medicine

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): NCT00199095


Locations
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Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Study Chair: Dieter Hoelzer, MD University Hospital Frankfurt, Medical Dept. II

Additional Information:
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ClinicalTrials.gov Identifier: NCT00199095     History of Changes
Other Study ID Numbers: GMALL11
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by Johann Wolfgang Goethe University Hospital:
ALL
Elderly
Chemotherapy
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
Cyclophosphamide
Methotrexate
Vincristine
Doxorubicin
Ifosfamide
Idarubicin
Mercaptopurine
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
Antineoplastic Agents
Immunosuppressive Agents