German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

Phase 4CompletedNCT00198991

Goethe University1,883 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. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,883

Conditions

Adult Acute Lymphocytic Leukemia

Interventions

Cyclophosphamide

DexamethasoneDRUG

Antileukemic drug

VincristineDRUG

Cytostatic drug

DaunorubicinDRUG

Cytostatic drug

AsparaginaseDRUG

Cytostatic drug

MethotrexateDRUG

Cytostatic drug

CytarabineDRUG

Cytostatic drug

MercaptopurineDRUG

Cytostatic drug

G-CSFDRUG

Growth factor

VindesineDRUG

Cytostatic drug

EtoposideDRUG

Cytostatic drug

PrednisoloneDRUG

Antileukemic drug

AdriamycinDRUG

Cytostatic drug

ThioguanineDRUG

Cytostatic drug

TeniposideDRUG

Cytostatic drug

CNS irradiationPROCEDURE

Cytostatic drug

Mediastinal IrradiationPROCEDURE

Irradiation

Stem cell transplantation (SCT)PROCEDURE

Stem cell transplantation

IdarubicinDRUG

Cytostatic drug

FludarabineDRUG

Cytostatic drug

CladribineDRUG

Cytostatic drug

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, thymic T, mature T) * Age 15-65 yrs (\*55-65 years if biologically younger according to general condition) * Written informed consent Exclusion Criteria: * Severe comorbidity or leukemia associated complications * Late relapse of pediatric ALL or ALL as second malignancy * Cytostatic pre-treatment * Pregnancy * Severe psychiatric illness or other circumstances which may compromise cooperation of the patient * Participation in other clinical trials interfering with the study therapy

Locations (1)

University of Frankfurt, Medical Dept. II

Frankfurt, Germany

Outcomes

Primary Outcomes

Remission rate

Rate of patients with complete remission

Time frame: day 46

Remission duration

Rate and probability of patients with ongoing remission after prior achievement of remission

Time frame: up to 10 years

Disease free survival

Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy

Time frame: up to 10 years

Overall survival

Rate and probability of patients remaining alive

Time frame: up to 10 years

Secondary Outcomes

Realisation of Stem cell transplantation (SCT)

Rate of patients receiving an SCT

Time frame: up to 10 years

Toxicity according to WHO/CTCAE

Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)

Time frame: after each cycle up to 2.5 years

Response assessment based on MRD

Rate of MRD response after specific cycles

Time frame: up to 5 years

Data from ClinicalTrials.gov

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