Chronic Lymphocytic LeukemiaPhase 3CLLNCT01657955
Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3 study testing Bendamustine Hydrochloride Injection and Chlorambucil in people with Chronic Lymphocytic Leukemia and Leukemia, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Leukemia, Neoplasms
- What is being tested?
- Bendamustine Hydrochloride Injection and Chlorambucil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Lu G Qiu, M.D. contact
China1 site, 1 recruiting
- Recruiting
Hematologic hospital of Chinese academy of medical sciences
Tianjin
Lu G Qiu, M.D.
Jian J Yu, Master, +8615336402752, yujj@lanjin.cn
About this study
Official title: 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).
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia, Neoplasms
- Being tested
- Bendamustine Hydrochloride Injection, Chlorambucil
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine Hydrochloride InjectionDrug
ChlorambucilDrug
Also called Leukeran
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine Hydrochloride Injection | Experimental | d1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles. Receives: Drug: Bendamustine Hydrochloride Injection |
| Chlorambucil | Active comparator | 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 ); Receives: Drug: Chlorambucil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Measured: 24 months
Secondary outcomes (3)
Progress free survival(PFS)
Measured: 24 months
Duration of Response (DR)
Measured: 24 months
Overall Survival(OS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJan 2011
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu G Qiu, M.D., Principal investigator, Hematologic Hospital of Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657955
- Sponsor's protocol ID
- RGN0117
- Acronym
- CLL
- Status last verified
- Aug 2012
- First submitted
- 2 Aug 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
- ClinicalTrials.gov ID
- NCT01657955
- Acronym / sponsor ID
- CLL / RGN0117
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia, Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bendamustine Hydrochloride Injection | Experimental | Drug: Bendamustine Hydrochloride Injectiond1-d2,i.v.gtt, 100mg/m2/d, 28 days per cycle, at most 6 cycles. |
| Chlorambucil | Active comparator | Drug: Chlorambucild1-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 ); |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bendamustine Hydrochloride Injection | Drug | Bendamustine Hydrochloride Injection |
| ChlorambucilAlso: Leukeran | Drug | Chlorambucil |
Primary outcome
Overall response rate (ORR)
Time frame: 24 months
3 secondary outcomes
Progress free survival(PFS)
Time frame: 24 months
Duration of Response (DR)
Time frame: 24 months
Overall Survival(OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu G Qiu, M.D. contact
Lu G Qiu, M.D. principal investigator
Hematologic Hospital of Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bendamustine Hydrochloride Injection and Chlorambucil in people with Chronic Lymphocytic Leukemia and Leukemia, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu G Qiu, M.D. (+86-02223909172), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.