Clinical trial · Observational
Retrospective Study: Efficacy and Safety of Chlorambucil + Rituximab in CLL Patients
A Retrospective Study to Assess the Efficacy and Safety of Chlorambucil Plus Rituximab as Front-line Therapy in Elderly and/or Unfit Patients Affected by B-cell Chronic Lymphocytic Leukemia
NCT01862445CI-TRIAL-00032189unknownClinicalTrials.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 is a non interventional study to evaluate the efficacy and safety of Chlorambucil plus Rituximab as firstline therapy in elderly and/or unfit patients affected by B-cell Chronic Lymphocytic Leukemia (B-CLL).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell | — | UNRESOLVED | — |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Elderly Patients | — | UNRESOLVED | — |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Untreated B-CLL | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Patients receiving Chlorambucil plus Rituximab
Primary outcomes (1)
- measure
- Number of responding patients.
- timeFrame
- 10 months from study entry
- description
- Overall response rate.
Secondary outcomes (4)
- measure
- Number of adverse events.
- timeFrame
- 24 months from study entry
- description
- Safety of Rituximab and Chlorambucil regimen (type, frequency and severity).
- measure
- Number of days from the first dose of treatment to re-treatment.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of B-CLL or Small Lymphocytic Lymphoma (SLL) according to the World Health Organisation (WHO) classification 2008; * Previously untreated B-CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 (Appendix G) undergone to first line of therapy with Chl-R; * All patients included in the study must have started treatment by December 2011; * Age ≥ 65 years or unfit pts ≥ 18 years old with a CIRS score ≥7 (Appendix E); * Eastern Cooperative Oncology Group Performance Status Grade of 0-2 (Appendix B) ; * Life expectancy \> 6 months; * Signed written informed consent according to ICH/EU/GCP and national local law. Exclusion Criteria: * Patients who have received prior therapy: chemotherapy and/or immunotherapy, stem cell transplantation, investigational drugs administered to treat B-CLL before Chl-R; * Transformation of B-CLL to aggressive lymphomas (Richter's Syndrome); * One or more individual organ/system impairment score of 4 as assessed by CIRS definition; * HIV infection; * Active, uncontrolled HCV and/or HBV infections or liver cirrhosis; * Patients who started Chl-R after December 2011.
References
Publications (0)
Data not yet available
No reference posted for this study.