This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
Every 4 weeks, 6 cycles
Every 4 weeks, 3 cycles
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, Austria
LKH Hochsteiermark; Abt. für Innere Medizin
Leoben, Austria
Kh Der Barmherzigen Schwestern; Interne I X
Linz, Austria
A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.
Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)
Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (\>)1500 per microliter (/µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC.
Time frame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24
Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)
Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.
Time frame: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)
Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.
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Linz, Austria
Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung
Linz, Austria
Landeskrankenhaus Rankweil; Interne E
Rankweil, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
Wels, Austria
Time frame: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
Time to Next Treatment - Percentage of Participants With an Event
Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.
Time frame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months
Time to Next Treatment - Time to Event
Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.
Time frame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months
Percentage of Participants With Adverse Events (AEs)
AEs were recorded from the date of first medication administration until 28 days after the last trial medication.
Time frame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.