Rituximab in the Treatment of Chronic Lymphocytic Leukemia, "CLL NIS"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 681
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
Study Overview
Brief Summary
This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CLL requiring treatment
- •Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
- •After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (>) 6 and/or creatinine clearance less than (<) 70 milliliters per minute (mL/min)
Exclusion Criteria
- •Participants with contraindication to rituximab treatment
Arms & Interventions
Participants With CLL
Participants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period.
Intervention: Rituximab (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
Time Frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (\>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.
Percentage of Participants Without Progression or Death
Time Frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
Disease progression was defined as the occurrence of at least one of the following: \>/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or \>/=50% increase in the number of circulating lymphocytes.
Secondary Outcomes
- Percentage of Participants With B-Symptoms(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With General Symptoms(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Progression and Death(From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months))
- Percentage of Participants Who Received Each Treatment During the Course of Study(Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month))
- Mean Body Weight(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Karnofsky Performance Status Index(Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months))
- Percentage of Participants With Best Overall Response (BOR)(From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months))