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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657955
Recruitment Status : Unknown
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : August 6, 2012
Last Update Posted : August 6, 2012
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Leukemia Neoplasms Drug: Bendamustine Hydrochloride Injection Drug: Chlorambucil Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
Study Start Date : January 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

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 Name: Leukeran

Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Progress free survival(PFS) [ Time Frame: 24 months ]
  2. Duration of Response (DR) [ Time Frame: 24 months ]
  3. Overall Survival(OS) [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657955

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Contact: Lu G Qiu, M.D. +86-02223909172
Contact: Jian J Yu, Master +86-15336402751

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Hematologic hospital of Chinese academy of medical sciences Recruiting
Tianjin, China
Contact: Lu G Qiu, M.D.         
Contact: Jian J Yu, Master    +8615336402752   
Principal Investigator: Lu G Qiu, M.D.         
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
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Principal Investigator: Lu G Qiu, M.D. Hematologic Hospital of Chinese Academy of Medical Sciences
Additional Information:
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Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd Identifier: NCT01657955    
Other Study ID Numbers: RGN0117
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents