Indolent B-Cell Non-Hodgkin's LymphomasPhase 2NCT04569838
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection
A Phase 2 study testing Bendamustine hydrochloride injection in people with Indolent B-Cell Non-Hodgkin's Lymphomas, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.
Trial summary
This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Indolent B-Cell Non-Hodgkin's Lymphomas
- What is being tested?
- Bendamustine hydrochloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 11 sitesChina
- Study dates
- May 2012to Aug 2016
- 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
- 1. Inert lymphoma, including follicular lymphoma (FL), extranodal marginal zone B-cell lymphomas of the mucosa-associated lymphoid tissue (MALT), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte B-cell lymphoma and chronic lymphoblastic leukemia (CLL).
- 2. At least one measurable lesion with the longest diameter > 1.5 cm and the short diameter > 1.0 cm, or the peripheral blood B lymphocyte ≥ 5.0×109/L.
- 3.Adequate laboratory indicators. 4. Has received one to three chemotherapy regimens (with or without rituximab) before enrollment.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 6. Understood and signed an informed consent form.
Who cannot join
- 1. Patients who could not tolerate bendamustine treatment according to the investigators' judgment.
- 2. Has received anti-tumor treatment (including major surgery) in the last 4 weeks.
- 3. Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma.
- 4. Has received corticosteroids regularly in the last 4 weeks. 5. Has a history of central nervous system disease or central nervous system disease.
- 6. Has other tumors. 7. Has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit.
- 8. Pregnant or breastfeeding women. 9. Has participated in other clinical trials within three months.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
First People's Hospital of Foshan
Foshan, Guangdong, 528000
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 215006
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection in Subjects With Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas
This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.
- Conditions
- Indolent B-Cell Non-Hodgkin's Lymphomas
- Being tested
- Bendamustine hydrochloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine hydrochloride injectionDrug
Bendamustine is a bifunctional alkylating agent. It cross-links DNA single strand and double strand by alkylation,then destroys the function and synthesis of DNA, and makes the DNA and protein, protein and protein cross-linking, has potential to treat various tumors
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine hydrochloride injection | Experimental | Bendamustine hydrochloride injection 120 mg/m² or 100 mg/m² intravenously (IV) on Day 1 and Day 2 of 21-day cycle (6-8 cycles maximum) for non-hodgkin's lymphomas or chronic lymphocytic leukemia. After 6-8 cycles, the course of treatment could be added based on patient's benefit and investigator's determination. Receives: Drug: Bendamustine hydrochloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: Baseline up to 30 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: Baseline up to 30 weeks
Secondary outcomes (2)
Progression Free Survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: Baseline up to 30 weeks
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: Baseline up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study startMay 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent B-Cell Non-Hodgkin's LymphomasStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569838
- Sponsor's protocol ID
- BDMS-C10IICS-PRT
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection in Subjects With Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas
- ClinicalTrials.gov ID
- NCT04569838
- Acronym / sponsor ID
- BDMS-C10IICS-PRT
- Conditions
- Indolent B-Cell Non-Hodgkin's Lymphomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Sep 2020 (actual)
- 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.
This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine hydrochloride injection | Experimental | Drug: Bendamustine hydrochloride injectionBendamustine hydrochloride injection 120 mg/m² or 100 mg/m² intravenously (IV) on Day 1 and Day 2 of 21-day cycle (6-8 cycles maximum) for non-hodgkin's lymphomas or chronic lymphocytic leukemia. After 6-8 cycles, the course of treatment could be added based on patient's benefit and investigator's determination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Inert lymphoma, including follicular lymphoma (FL), extranodal marginal zone B-cell lymphomas of the mucosa-associated lymphoid tissue (MALT), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte B-cell lymphoma and chronic lymphoblastic leukemia (CLL).
- 2. At least one measurable lesion with the longest diameter > 1.5 cm and the short diameter > 1.0 cm, or the peripheral blood B lymphocyte ≥ 5.0×109/L.
- 3.Adequate laboratory indicators. 4. Has received one to three chemotherapy regimens (with or without rituximab) before enrollment.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 6. Understood and signed an informed consent form.
Key exclusion criteria (6 listed)
- 1. Patients who could not tolerate bendamustine treatment according to the investigators' judgment.
- 2. Has received anti-tumor treatment (including major surgery) in the last 4 weeks.
- 3. Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma.
- 4. Has received corticosteroids regularly in the last 4 weeks. 5. Has a history of central nervous system disease or central nervous system disease.
- 6. Has other tumors. 7. Has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit.
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 injectionBendamustine is a bifunctional alkylating agent. It cross-links DNA single strand and double strand by alkylation,then destroys the function and synthesis of DNA, and makes the DNA and protein, protein and protein cross-linking, has potential to treat various tumors | Drug | Bendamustine hydrochloride injection |
Primary outcome
Objective Response Rate（ORR）
Time frame: Baseline up to 30 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
Duration of Response (DOR)
Time frame: Baseline up to 30 weeks
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: Baseline up to 30 weeks
Overall Survival (OS)
Time frame: Baseline up to 30 weeks
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 30 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites 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 in people with Indolent B-Cell Non-Hodgkin's Lymphomas, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 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 5 inclusion and 6 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 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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: Baseline up to 30 weeks). The study lists 2 primary outcomes in all. 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 30 Sep 2020.