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Completed

NCT Number: NCT00199095

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

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

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Key information

Conditions

Adult Acute Lymphocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Medical Dept. II

Frankfurt, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adriamycin

Drug

Cyclophosphamide

Drug

Cytarabine

Drug

Dexamethasone

Drug

Idarubicin

Drug

ifosfamide

Drug

methotrexate

Drug

mercaptopurine

Drug

VM26

Drug

Vincristine

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2003
Study completion
2003
First posted
Sep 20, 2005
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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