German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

NCT ID: NCT00199069

Last Updated: 2023-03-17

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

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-04-30

Study Completion Date

2001-05-31

Brief Summary

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The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',

Detailed Description

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Conditions

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Adult Acute Lymphocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Asparaginase

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Daunorubicin, Adriamycin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Mitoxantrone

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

6-Mercaptopurine

Intervention Type DRUG

6-Thioguanine

Intervention Type DRUG

VM26

Intervention Type DRUG

Dexamethasone / Prednisolone

Intervention Type DRUG

CNS Irradiation

Intervention Type PROCEDURE

Mediastinal Irradiation

Intervention Type PROCEDURE

Stem Cell Transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute Lymphocytic Leukemia
* Age 15 - 65 years

Exclusion Criteria

* Serious secondary diseases which may compromise intensified chemotherapeutical treatment
* Serious psychiatric diseases, which may compromise compliance with therapy
* HIV-1 or HIV-2 Infection
* Pretreatment \> 2 weeks or chemotherapy other than Vincristine and Steroids
* Patients without central diagnosis who cannot be allocated to a risk group
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Nicola Goekbuget

Study Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dieter Hoelzer, MD, PhD

Role: STUDY_CHAIR

University of Frankfurt, Medical Department 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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GMALL09

Identifier Type: -

Identifier Source: org_study_id

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