Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01109264
First received: April 19, 2010
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Bendamustine hydrochloride injection Drug: Chlorambucil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients |
Resource links provided by NLM:
Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:
Primary Outcome Measures:
- Objective Response Rate (ORR) [ Time Frame: after 3 cycles and 6 cycles ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free Survival (PFS) [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
- Duration of Remission (DR) [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
- Overall Survival (OS) [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
- The incidence and severity of adverse events [ Time Frame: Up to 2 years after enrollment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 144 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bendamustine Hydrochloride |
Drug: Bendamustine hydrochloride injection
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
|
| Active Comparator: Chlorambucil |
Drug: Chlorambucil
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109264
Locations
| China | |
| Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine | |
| Shanghai, China | |
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Investigators
| Principal Investigator: | Zhixiang Shen, Dr. | Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine |
More Information
No publications provided
| Responsible Party: | Jiangsu Simcere Pharmaceutical R&D Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT01109264 History of Changes |
| Other Study ID Numbers: | SIM-79-001 |
| Study First Received: | April 19, 2010 |
| Last Updated: | May 18, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:
|
Chronic Lymphocytic Leukemia Bendamustine Hydrochloride Chlorambucil |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Chlorambucil Nitrogen Mustard Compounds Bendamustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013