Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase

Completed

Phase 3

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Rituximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01118234

Mabtenance

Details and patient eligibility

About

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

Enrollment

256 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

B-CLL
Age >18
ECOG performance status 0-2
Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
Patient must be in complete remission or partial remission after an induction treatment containing rituximab
ANC (absolute neutrophil count) > 1,0 x 10e9 /L
Life expectancy > 6 months
Patient´s written informed consent
Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter

Exclusion criteria

Active uncontrolled bacterial, viral or fungal infection
Significantly reduced organ functions and bone marrow dysfunction not due to CLL
creatinine clearance of below 30mL/min
Patients with a history of other malignancies within 2 years prior to study entry
Patients with a history of severe cardiac disease
Other known comorbidity with the potential to dominate survival
Transformation to aggressive B-cell malignancy
Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
Medical condition requiring prolonged (> 1 month) use of oral corticosteroids
Pregnant or breast feeding women
Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent