Non-Hodgkin Lymphoma by Clinical CoursePhase 3NCT01570049
Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma
A Phase 3 study testing Bendamustine in people with Non-Hodgkin Lymphoma by Clinical Course, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 2 sites in China.
Trial summary
The purpose of this study is to determine whether bendamustine HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Hodgkin Lymphoma by Clinical Course
- What is being tested?
- Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2010to Dec 2012
- 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
- 18 to 75 years
- B-cell indolent lymphoma proved by biopsy, exclude CLL/SLL
- Rituximab refractory or relapsed lymphoma patients
- At least 1 measurable tumor with shortest diameter being of > 1.0cm and longest diameter being of > 1.5cm
- ECOG PS ≤ 2
- Anticipated Survival is more than 3 months
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- Hematopoietic function is normal during 14 days before enrollment (unless those abnormities related to lymphoma aggression), including: hemoglobin (Hb) ≥ 8.0g/dl (5.0mmol/L); absolute neutrophil count (ANC) ≥ 1.5X109/L; Platelet count (PLT) ≥ 80X109/L. Acceptable range for abnormities related to lymphoma aggression: Platelet count (PLT) ≥ 50X109/L; White blood cell count (WBC) ≥ 3.5X109/L; Absolute neutrophil count (ANC) ≥ 1.0X109/L
- Female subjects should not be pregnant and breast-feed, should have contraceptive method during the clinical trial and 12 months thereafter.
- Subject (or his/her legal representative) agrees to participate the trial and sign the informed consent form
Who cannot join
- Those who can not tolerate bendamustine treatment according to investigators view
- Transferred to high grade malignant lymphoma (from low grade follicular lymphoma)
- 3b grade follicular lymphoma
- With central nervous system diseases or medical history (e.g., central nervous system lymphoma or lymphoma related meningitis )
- With other anticancer treatment during the last 4 weeks
- Regularly administrated corticosteroid during the last 4 weeks, unless the dose is less or equivalent to 20mg/d prednisone
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- Had tumors or have other tumors, not including non-melanoma skin cancers and cervical carcinoma in situ be treated properly
- Underwent surgical operation within 28 days before enrollment (exclude lymph node biopsy)
- Renal disfunction: serum creatinine is more than 1.5 times of upper limit of normal value
- Hepatic insufficiency: serum total bilirubin is > 1.5 times of upper limit of normal value; AST, ALT is > 2.5 times of upper limit of normal value
- Known HIV infection or HBV, HCV related active infections; HBsAg is positive; HBcAb is positive and virus copy number is > 1000
- For patients with other severe medical diseases interfering with their participations of this study(e.g., infections and diabetes not controlled well, gastric ulcer, other lung diseases, active autoimmune diseases), the suitability of participation is judged by investigators
- Patients participated in other clinical studies and got medical treatments within 30 days prior to enrollment of this trial
- Other medical and psychological conditions that influence the patients participation or signing of informed consent form
Trial locations and contacts
2 sites in 1 country.
Huaqing Wang, Master contact
China2 sites, 2 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Huaqing Wang, Master, +86-022-2334-0123
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Huaqing Wang, Master
Jian J Yu, Master, +8615336402751, yujj@lanjin.cn
About this study
Official title: A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma
The purpose of this study is to determine whether bendamustine HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.
Read the detailed description
This is multicenter, open label study to evaluate the safety and efficacy of bendamustine HCl in patients with indolent Non-hodgkin's lymphoma and relapsed after rituximab treatment. This injection will be given through i.v. infusion in >= 60 minutes on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for up to 8 cycles unless progressive disease or unacceptable toxicity take place. Patients will be followed for up to 1 year before evaluating progression free survival (PFS) and overall survival (OS).
- Conditions
- Non-Hodgkin Lymphoma by Clinical Course
- Being tested
- Bendamustine
- Keywords
- Single arm, Open label, Bendamustine HCl, Non-hodgkin's lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
for injection
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine | Experimental | Dose of 120 mg/m2/day on Day 1 and Day 2 of each treatment cycle (every 21 days), to a maximum of 8 cycles. Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.
Measured: 18 months
Secondary outcomes (3)
Safety profile of Bendamustine hydrochloride in this patient population
Measured: 18 months
Progression free survival (PFS)
Measured: 18 months
Overall survival (OS)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startApr 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma by Clinical CourseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huaqing Wang, master, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570049
- Sponsor's protocol ID
- RGB-NHL
- Status last verified
- Aug 2012
- First submitted
- 29 Mar 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm Clinical Trial in Patients With Rituximab Refractory B-cell Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT01570049
- Acronym / sponsor ID
- RGB-NHL
- Conditions
- Non-Hodgkin Lymphoma by Clinical Course
- Keywords
- Single arm, Open label, Bendamustine HCl, Non-hodgkin's lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Apr 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 HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.
Detailed description
This is multicenter, open label study to evaluate the safety and efficacy of bendamustine HCl in patients with indolent Non-hodgkin's lymphoma and relapsed after rituximab treatment. This injection will be given through i.v. infusion in >= 60 minutes on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for up to 8 cycles unless progressive disease or unacceptable toxicity take place. Patients will be followed for up to 1 year before evaluating progression free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine | Experimental | Drug: BendamustineDose of 120 mg/m2/day on Day 1 and Day 2 of each treatment cycle (every 21 days), to a maximum of 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 75 years
- B-cell indolent lymphoma proved by biopsy, exclude CLL/SLL
- Rituximab refractory or relapsed lymphoma patients
- At least 1 measurable tumor with shortest diameter being of > 1.0cm and longest diameter being of > 1.5cm
- ECOG PS ≤ 2
Key exclusion criteria (14 listed)
- Those who can not tolerate bendamustine treatment according to investigators view
- Transferred to high grade malignant lymphoma (from low grade follicular lymphoma)
- 3b grade follicular lymphoma
- With central nervous system diseases or medical history (e.g., central nervous system lymphoma or lymphoma related meningitis )
- With other anticancer treatment during the last 4 weeks
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 |
|---|---|---|
| Bendamustinefor injection | Drug | Bendamustine |
Primary outcome
Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.
Time frame: 18 months
3 secondary outcomes
Safety profile of Bendamustine hydrochloride in this patient population
Time frame: 18 months
Progression free survival (PFS)
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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.
Huaqing Wang, Master contact
Huaqing Wang, master principal investigator
Tianjin Medical University Cancer Institute and Hospital
2 sites 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 in people with Non-Hodgkin Lymphoma by Clinical Course, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 2 sites 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 9 inclusion and 14 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 2 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 2 sites 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 Huaqing Wang, Master (+86-022-2334-0123), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy. (time frame: 18 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 2 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.