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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd Identifier:
First received: August 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Bendamustine Hydrochloride Injection
Drug: Chlorambucil
Phase 3

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 Shandong Lanjin Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progress free survival(PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall Survival(OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01657955

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

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
Principal Investigator: Lu G Qiu, M.D. Hematologic Hospital of Chinese Academy of Medical Sciences
  More Information

Additional Information:
Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd Identifier: NCT01657955     History of Changes
Other Study ID Numbers: RGN0117 
Study First Received: August 2, 2012
Last Updated: August 3, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Bendamustine Hydrochloride
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016