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


Phase 4
65 Years
N/A
Not Enrolling
Both
Adult Acute Lymphocytic Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Dieter Hoelzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Frankfurt, Medical Dept. II

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GMALL11

NCT ID:

NCT00199095

Start Date:

February 1997

Completion Date:

Related Keywords:

  • Adult Acute Lymphocytic Leukemia
  • ALL
  • Elderly
  • Chemotherapy
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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