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

NCT ID: NCT00199095

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Study Completion Date

2003-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Adult Acute Lymphocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Adriamycin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Idarubicin

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

VM26

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Nicola Goekbuget

Head of GMALL

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dieter Hoelzer, MD

Role: STUDY_CHAIR

University Hospital Frankfurt, Medical Dept. II

Locations

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University Hospital, Medical Dept. II

Frankfurt, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.studienregister-online.de

German Leukemia Trial Registry

Other Identifiers

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GMALL11

Identifier Type: -

Identifier Source: org_study_id

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