CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- Registration Number
- NCT02013817
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- Adult patients, >/= 18 years of age
- B-cell CLL
- No previous chemotherapy, radiotherapy, or immunotherapy
- Reduced organ function, or bone marrow dysfunction not due to CLL
- Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
- Patients with a history of severe cardiac disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MabThera/Rituxan rituximab [MabThera/Rituxan] - MabThera/Rituxan cyclophosphamide - MabThera/Rituxan fludarabine -
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) Weeks 1, 5, 9, 12, 13, 17, 21 and 24 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.
- Secondary Outcome Measures
Name Time Method Time to Next Treatment - Percentage of Participants With an Event 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 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.
Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment) Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose) 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.
Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment) Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose) 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.
Time to Next Treatment - Time to Event 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 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.
Percentage of Participants With Adverse Events (AEs) Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication. AEs were recorded from the date of first medication administration until 28 days after the last trial medication.
Trial Locations
- Locations (8)
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.
🇦🇹Linz, Austria
Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung
🇦🇹Linz, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
🇦🇹Salzburg, Austria
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
🇦🇹Wels, Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
🇦🇹Innsbruck, Austria
Landeskrankenhaus Rankweil; Interne E
🇦🇹Rankweil, Austria