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Completed

NCT Number: NCT00198978

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

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.

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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

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Frankfurt, 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, 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

Treatment and study plan

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

Drug

Primary outcomes

  1. Remission rate (cytologic, molecular)

    Time frame: After induction; approximately 6 wks (exact time frame not specified)

  2. Toxicity (CTC)

    Time frame: After each cycle; time-frame not specified

  3. Survival time, Duration of Remission

    Time frame: at 3 and 5 years

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2011
Study completion
2014
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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