Clinical trial · Interventional
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
NCT01109264CI-TRIAL-00011834completedPhase 2ClinicalTrials.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)
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine hydrochloride injection | Drug | Bendamustine | ALIAS |
| Chlorambucil | Drug | Chlorambucil | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bendamustine Hydrochloride
- interventionNames
- Drug: Bendamustine hydrochloride injection
- type
- ACTIVE_COMPARATOR
- label
- Chlorambucil
- interventionNames
- Drug: Chlorambucil
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- after 3 cycles and 6 cycles
Secondary outcomes (4)
- measure
- Progression-free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of CLL according to National Cancer Institute (NCI) Working Group criteria * No prior treatment for CLL * Binet stage B or C * ECOG performance status ≤ 2 * Life expectancy ≥3 months * AST and ALT ≤ 3 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance ≥ 40 mL/min * Written informed consent Exclusion Criteria: * Patients were diagnosed with or treated for malignant tumors other than CLL (including central nervous system lymphoma) within one year prior to entering the study * Transformation to Richter's syndrome, or prolymphocytic leukemia (PLL) * Autoimmune hemolytic anemia requiring glucocorticoid therapy * Autoimmune thrombocytopenia requiring glucocorticoid therapy * Participation in any other clinical trials within 4 weeks prior to study entry * Any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction * Patients received major surgery within 30 days prior to study entry * Pregnant or lactating women * Allergic to study drug or mannitol
References
Publications (0)
Data not yet available
No reference posted for this study.