German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Phase 4CompletedNCT00199056

Goethe University225 enrolled

Overview

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

225

Conditions

Adult Acute Lymphocytic Leukemia

Interventions

Dexamethasone / PrednisoloneDRUG

CyclophosphamideDRUG

MethotrexateDRUG

Vincristine / VindesineDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T) * Age 15-65 yrs (\*55-65 years if biologically younger according to general condition) Exclusion Criteria: * Severe comorbidity * Cytostatic pre-treatment * Pregnancy * Missing written informed consent

Locations (1)

University Hospital, Medical Dept. II

Frankfurt, Germany

Outcomes

Primary Outcomes

Remission rate,Remission duration,Disease free survival,Overall survival

Secondary Outcomes

Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD

Data from ClinicalTrials.gov

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