Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

Leukemia Clinical Trial

— CLL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01657955
• Other study ID #: RGN0117
• Status: Recruiting
• Phase: Phase 3
• First received: August 2, 2012
• Last updated: August 3, 2012
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2012
• Source: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Contact: Lu G Qiu, M.D.
• Phone: +86-02223909172
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients must have a diagnosis of CLL;

• No prior or no standard treatment for CLL;

• Binet stage B, C or symptomatic stage A;

• Needs treatment to control diseases;

• (Eastern Cooperative Oncology Group)ECOG performance status = 2

• Life expectancy =3 months

• Written informed consent

Exclusion Criteria:

• Patients were diagnosed with or treated for malignant tumors other than CLL (including active 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

• Alanine aminotransferase(ALT)>3 times upper limits of normal value, Aspartate aminotransferase(AST)>3 times upper limits of normal value, Total bilirubin(TBIL)>2 times upper limits of normal value, serum creatinine>1.5 times upper limits of normal value;

• Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases;

• Serious or uncontrolled infections;

• Central nervous system dysfunction with clinical symptoms;

• Patients received major surgery within 30 days prior to study entry;

• Pregnant or lactating women

• Allergic to study drug or mannitol

• Participation in any other clinical trials within 3 months prior to study entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Neoplasms

Intervention

Drug:
• Bendamustine Hydrochloride Injection

• Chlorambucil

Locations

Country	Name	City	State
China	Hematologic hospital of Chinese academy of medical sciences	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Lanjin Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)		24 months	No
Secondary	Progress free survival(PFS)		24 months	No
Secondary	Duration of Response (DR)		24 months	No
Secondary	Overall Survival(OS)		24 months	No

External Links

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