Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

Conditions

• Adult Acute Lymphocytic Leukemia

Interventions

DRUG

Cyclophosphamide

DRUG

Dexamethasone / Prednisolone

DRUG

Vincristine

DRUG

Daunorubicin

DRUG

Asparaginase

DRUG

Methotrexate

DRUG

Cytarabine

DRUG

Mercaptopurine

DRUG

G-CSF

DRUG

Vindesine

DRUG

VP16

DRUG

Adriamycin

DRUG

Thioguanine

DRUG

VM26

DRUG

Rituximab

PROCEDURE

CNS irradiation

PROCEDURE

Mediastinal irradiation (if residual TU)

PROCEDURE

Stem cell transplantation

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital

  lead OTHER

Principal Investigators

• Dieter Hoelzer, MD,PhD · University Hospital, Medical Dept. II

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-04-30

Primary Completion

2009-03-31

Completion

2009-03-31

Countries

• Germany

Study Locations