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

Goethe University1 site in 1 country40 target enrollmentFebruary 1997

ConditionsAdult Acute Lymphocytic Leukemia

DrugsAdriamycin Cyclophosphamide Cytarabine Dexamethasone Idarubicin Ifosfamide Methotrexate Mercaptopurine VM26 Vincristine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Adult Acute Lymphocytic Leukemia
Sponsor: Goethe University
Enrollment: 40
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 1997

End Date

June 2003

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Goethe University

Responsible Party

Principal Investigator

Nicola Goekbuget

Head of GMALL

Goethe University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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