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Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)


Phase 4
55 Years
N/A
Open (Enrolling)
Both
Adult Acute Lymphocytic Leukemia

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Trial Information

Multicenter Study To Optimize Treatment in Elderly Patients (> 55 Years, No Upper Age Limit) With Acute Lymphoblastic Leukemia (GMALL Elderly 1/2003)(Amend 2)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Remission rate (cytologic, Remission rate (molecular), Survival time, Duration of Remission, Toxicity (CTC, Treatment realization

Principal Investigator

Dieter Hoelzer, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Frankfurt, Medical Dept. II

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GMALL02

NCT ID:

NCT00198978

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Adult Acute Lymphocytic Leukemia
  • ALL
  • Treatment
  • Elderly
  • De novo
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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