Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

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

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

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Leukemia; Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: Chlorambucil; Drug: Bendamustine Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jian J Yu, Master; Phone Number: +86-15336402751; Email: yujj@lanjin.cn
• Study Contact Backup: Name: Lu G Qiu, M.D.; Phone Number: +86-02223909172

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Hematologic hospital of Chinese academy of medical sciences
    • Contact: Lu G Qiu, M.D.
    • Contact: Jian J Yu, Master; Phone Number: +8615336402752; Email: yujj@lanjin.cn
    • Principal Investigator: Lu G Qiu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bendamustine Hydrochloride Injection; d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles.	Drug: Bendamustine Hydrochloride Injection
Active Comparator: Chlorambucil; d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC≥4×109 /L at d12-d14 ); d1-d2, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles(if WBC<4×109 /L at d12-d14 );	Drug: Chlorambucil; Other Names: Leukeran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR)	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Response (DR)	24 months
Progress free survival(PFS)	24 months
Overall Survival(OS)	24 months

Collaborators and Investigators

• Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Lu G Qiu, M.D., Hematologic hospital of Chinese academy of medical sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Estimate): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 3, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Bendamustine Hydrochloride; Chlorambucil
• Other Study ID Numbers: RGN0117