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

Goethe University

Status and phase

Completed

Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Treatments

Drug: Methotrexate

Drug: VM26

Drug: Idarubicin

Drug: Cyclophosphamide

Drug: Cytarabine

Drug: Vincristine

Drug: Ifosfamide

Drug: Mercaptopurine

Drug: Dexamethasone

Drug: Adriamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00199095

GMALL11

Details and patient eligibility

About

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

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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