Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
This study is currently recruiting participants.
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor:
Shandong Lanjin Pharmaceuticals Co.,Ltd
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
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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
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:
|
Neoplasms Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Chlorambucil Nitrogen Mustard Compounds Bendamustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013