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

Phase 4CompletedNCT00199069

Goethe University720 enrolled

Overview

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',

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

720

Conditions

Adult Acute Lymphocytic Leukemia

Interventions

AsparaginaseDRUG

VincristineDRUG

Daunorubicin, AdriamycinDRUG

CyclophosphamideDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital, Medical Dept. II

Frankfurt, Germany

Outcomes

Primary Outcomes

remission rate, disease free survival, overall survival

Secondary Outcomes

death in induction, toxicity, time and dose compliance

Data from ClinicalTrials.gov

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