Clinical trial · Observational
A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Rituximab in the Treatment of Chronic Lymphocytic Leukemia, "CLL NIS"
NCT01178086CI-TRIAL-00035166completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Participants With CLL
- description
- 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.
- interventionNames
- Drug: Rituximab
Primary outcomes (2)
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDReiser 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. PMID 29393986