Chronic Lymphocytic LeukemiaPhase 2NCT01109264
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
A Phase 2 study testing Bendamustine hydrochloride injection and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- 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
- 147 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Aug 2013
- Phase
- Phase 2
- 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 according to National Cancer Institute (NCI) Working Group criteria
- No prior treatment for CLL
- Binet stage B or C
- ECOG performance status ≤ 2
- Life expectancy ≥3 months
- AST and ALT ≤ 3 x ULN; Total bilirubin ≤ 2 x ULN; Creatinine clearance ≥ 40 mL/min
- Written informed consent
Who cannot join
- Patients were diagnosed with or treated for malignant tumors other than CLL (including 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
- Participation in any other clinical trials within 4 weeks prior to study entry
- Any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction
Show all 9Show fewer
- Patients received major surgery within 30 days prior to study entry
- Pregnant or lactating women
- Allergic to study drug or mannitol
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai
About this study
Official title: Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia
Read the detailed description
Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Bendamustine hydrochloride injection, Chlorambucil
- Keywords
- Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Chlorambucil
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine hydrochloride injectionDrug
d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
ChlorambucilDrug
d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine Hydrochloride | Experimental | Not described Receives: Drug: Bendamustine hydrochloride injection |
| Chlorambucil | Active comparator | Not described Receives: Drug: Chlorambucil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: after 3 cycles and 6 cycles
Secondary outcomes (4)
Progression-free Survival (PFS)
Measured: December 2013
Duration of Remission (DR)
Measured: December 2013
Overall Survival (OS)
Measured: December 2013
The incidence and severity of adverse events
Measured: Up to 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2013
- Study completionAug 2013
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.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhixiang Shen, Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109264
- Sponsor's protocol ID
- SIM-79-001
- Status last verified
- Aug 2013
- First submitted
- 19 Apr 2010
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. 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
- NCT01109264
- Acronym / sponsor ID
- SIM-79-001
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Bendamustine Hydrochloride, Chlorambucil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Apr 2010 (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.
To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia
Detailed description
Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bendamustine Hydrochloride | Experimental | Drug: Bendamustine hydrochloride injection |
| Chlorambucil | Active comparator | Drug: Chlorambucil |
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 according to National Cancer Institute (NCI) Working Group criteria
- No prior treatment for CLL
- Binet stage B or C
- ECOG performance status ≤ 2
- Life expectancy ≥3 months
Key exclusion criteria (9 listed)
- Patients were diagnosed with or treated for malignant tumors other than CLL (including 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
- Participation in any other clinical trials within 4 weeks prior to study entry
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 injectiond1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles | Drug | Bendamustine Hydrochloride |
| Chlorambucild1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles | Drug | Chlorambucil |
Primary outcome
Objective Response Rate (ORR)
Time frame: after 3 cycles and 6 cycles
4 secondary outcomes
Progression-free Survival (PFS)
Time frame: December 2013
Duration of Remission (DR)
Time frame: December 2013
Overall Survival (OS)
Time frame: December 2013
The incidence and severity of adverse events
Time frame: Up to 2 years after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
Related trials for Chronic Lymphocytic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Zhixiang Shen, Dr. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine hydrochloride injection and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by Jiangsu Simcere Pharmaceutical 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 9 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: finished, as of the sponsor's last update on 23 Aug 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: after 3 cycles and 6 cycles). 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 23 Aug 2013.