Chronic Lymphocytic Leukemia
Conditions
Keywords
CLL, Rituximab, Maintenance
Brief summary
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.
Interventions
DRUGRituximab
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
Sponsors
Roche Pharma AG
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 48 months | Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| conversion rate to MRD negative | 48 months | — |
| median MRD levels | 48 months | — |
| conversation rate to CR | 48 months | — |
| effect of MRD levels on clinical PFS and OS | 48 months | — |
| MRD (minimal residual disease) progression free survival | 48 months | Minimal residual disease progression-free survival is defined as the period from randomization until increase of MRD levels in peripheral blood above 10-3 or, if above 10-3 before, increase of one common logarithm. |
| time to next treatment | 48 months | — |
| overall survival | 48 months | — |
| Safety of Rituximab maintenance treatment in patients with CLL | 48 months | All grades of infections and G3/4 other clinical adverse events will be documented using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 |
| benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression | 48 months | — |
| event free survival | 48 months | — |
Countries
Austria, Czechia, Slovakia
Outcome results
None listed