Back to resultsCHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
Primary Purpose
Lymphocytic Leukemia, Chronic
Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
rituximab [MabThera/Rituxan]
fludarabine
cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Lymphocytic Leukemia, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- B-cell CLL
- No previous chemotherapy, radiotherapy, or immunotherapy
Exclusion Criteria:
- 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.
Sites / Locations
- Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
- LKH Hochsteiermark; Abt. für Innere Medizin
- Kh Der Barmherzigen Schwestern; Interne I X
- A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.
- Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung
- Landeskrankenhaus Rankweil; Interne E
- Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
- Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MabThera/Rituxan
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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 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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02013817
Brief Title
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
Official Title
CHAIROS - Effect of Early Brief Intensification by Chemoimmunotherapy With FCR Followed by FR and Rituximab Maintenance on Clinical Response in Chemo-naïve Patients With B-CLL
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 11, 2005 (Actual)
Primary Completion Date
September 24, 2012 (Actual)
Study Completion Date
September 24, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Leukemia, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MabThera/Rituxan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
rituximab [MabThera/Rituxan]
Intervention Description
Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
Intervention Type
Drug
Intervention Name(s)
fludarabine
Intervention Description
Every 4 weeks, 6 cycles
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Every 4 weeks, 3 cycles
Primary Outcome Measure Information:
Title
Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)
Description
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)
Title
Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)
Description
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 Frame
Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)
Title
Time to Next Treatment - Percentage of Participants With an Event
Description
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
Title
Time to Next Treatment - Time to Event
Description
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
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
B-cell CLL
No previous chemotherapy, radiotherapy, or immunotherapy
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
LKH Hochsteiermark; Abt. für Innere Medizin
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
Kh Der Barmherzigen Schwestern; Interne I X
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Landeskrankenhaus Rankweil; Interne E
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels; Iii. Interne Abt.
City
Wels
ZIP/Postal Code
4600
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
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