Clinical trial NCT01178086: A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Official title: Rituximab in the Treatment of Chronic Lymphocytic Leukemia, "CLL NIS"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 681
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with CLL on chemotherapy receiving rituximab

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate
timeFrame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
measure: Percentage of Participants Without Progression or Death
timeFrame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
Secondary outcomes:
measure: Percentage of Participants With Progression and Death
timeFrame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
measure: Percentage of Participants Who Received Each Treatment During the Course of Study
timeFrame: Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)
measure: Mean Body Weight
timeFrame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
measure: Percentage of Participants With Karnofsky Performance Status Index
timeFrame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
measure: Percentage of Participants With General Symptoms
timeFrame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
measure: Percentage of Participants With B-Symptoms
timeFrame: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)
measure: Percentage of Participants With Best Overall Response (BOR)
timeFrame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)
Other outcomes:
Locations:
city: Frechen
country: Germany
facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Reiser M, Dorfel S, Hensel M, Hoesl M, Jordan WO, Koenigsmann M, Meyer D, Reichert D, Schwarzer A, Marquardt M, Kellershohn K, Jentsch-Ullrich K. Rituximab in combination with chemotherapy for the treatment of chronic lymphocytic leukaemia in clinical practice. Eur J Haematol. 2018 May;100(5):455-464. doi: 10.1111/ejh.13040. Epub 2018 Mar 22.