Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Sponsor:
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01657955
First received: August 2, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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
Leukemia
Neoplasms
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

  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;
  • 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 ClinicalTrials.gov identifier: NCT01657955

Contacts
Contact: Lu G Qiu, M.D. +86-02223909172
Contact: Jian J Yu, Master +86-15336402751 yujj@lanjin.cn

Locations
China
Hematologic hospital of Chinese academy of medical sciences Recruiting
Tianjin, China
Contact: Lu G Qiu, M.D.         
Contact: Jian J Yu, Master    +8615336402752    yujj@lanjin.cn   
Principal Investigator: Lu G Qiu, M.D.         
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
Investigators
Principal Investigator: Lu G Qiu, M.D. Hematologic Hospital of Chinese Academy of Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov 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
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Chlorambucil
Nitrogen Mustard Compounds
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014