Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01109264

Enrollment

147

Registered

2010-04-23

Start date

2010-03-31

Completion date

2013-08-31

Last updated

2013-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Chlorambucil

Brief summary

To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Detailed description

Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.

Interventions

DRUGBendamustine hydrochloride injection

d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles

DRUGChlorambucil

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR)	after 3 cycles and 6 cycles

Secondary

Measure	Time frame
Progression-free Survival (PFS)	December 2013
Duration of Remission (DR)	December 2013
Overall Survival (OS)	December 2013
The incidence and severity of adverse events	Up to 2 years after enrollment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026