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

Johann Wolfgang Goethe University Hospital

Status and phase

Completed

Phase 4

Conditions

Adult Acute Lymphocytic Leukemia

Treatments

Drug: Rituximab

Drug: Asparaginase

Procedure: Mediastinal irradiation (if residual TU)

Procedure: Stem cell transplantation

Drug: Mercaptopurine

Drug: Dexamethasone / Prednisolone

Drug: Vindesine

Drug: Cyclophosphamide

Procedure: CNS irradiation

Drug: Adriamycin

Drug: Daunorubicin

Drug: Methotrexate

Drug: VM26

Drug: Thioguanine

Drug: G-CSF

Drug: Vincristine

Drug: Cytarabine

Drug: VP16

Study type

Interventional

Funder types

Other

Identifiers

NCT00199004

GMALL03

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

B-precursor ALL (common / pre B-ALL)
Standard risk
CD20 expression >20%
Ph/BCR-ABL negative
Age 15-65 years (55-65 if biologically younger)
Written informed consent

Exclusion criteria

Severe complications due to leukemia or secondary illnesses
Late relapse of childhood ALL
Cytostatic pretreatment
Pregnancy
Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
Known severe allergy to foreign proteins