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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199095
First received: September 12, 2005
Last updated: May 16, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: February 1997
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00199095

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00199095     History of Changes
Other Study ID Numbers: GMALL11
Study First Received: September 12, 2005
Last Updated: May 16, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
ALL
Elderly
Chemotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Isophosphamide mustard
Dexamethasone
 Doxorubicin
Idarubicin
Ifosfamide
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013