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

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

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2005-12-31

Brief Summary

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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.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dexamethasone / Prednisolone

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Vincristine / Vindesine

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Asparaginase

Intervention Type DRUG

G-CSF

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

6-Mercaptopurine

Intervention Type DRUG

VP16

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Thioguanine

Intervention Type DRUG

VM26

Intervention Type DRUG

Idarubicin

Intervention Type DRUG

Fludarabine

Intervention Type DRUG

Ifosfamide

Intervention Type DRUG

CNS irradiation

Intervention Type PROCEDURE

Mediastinal irradiation (if residual tumor)

Intervention Type PROCEDURE

stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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)