B-Cell LymphomaPhase 1NCT03003039
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
A Phase 1 study testing GB241 and Rituximab in people with B-Cell Lymphoma, run by Nanjing Yoko Biomedical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- GB241 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2017to 20 May 2019
- Phase
- Phase 1
- 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
- having histologically confirmed NHL expressing CD20 antigen
- having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
- signed an informed consent form which was approved by the institutional review board of the respective medical center
- aged from 18 to 75 years
- ECOG performance status of 0 to 1
- expected survival of at least ≥ 3 months
Who cannot join
- had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy
- participating in other clinical trial within 30 days before enrolment
- with serious hematologic dysfunction (white blood cell count of <3.0×103/uL; absolute neutrophil count of <1.5×103/ uL; platelet count of < 75×103/uL; hemoglobin level of < 8.0 g/dL); hepatic dysfunction (total bilirubin level of > 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN; renal dysfunction (serum creatinine level of > 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) > 1.5 × ULN (unless on therapeutic coagulation)
- had received live vaccine within 4 weeks prior to study entry
- with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease
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- seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated
- recent major surgery (within 28 days prior to study entry )
- with a history of allergic reaction or protein product allergy including murine proteins
- pregnant or lactating or not accepted birth control methods including male patients
- patients considered unsuitable by PI
- previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer
- active opportunistic infections and other serious non neoplastic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100076
About this study
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.
- Conditions
- B-Cell Lymphoma
- Being tested
- GB241, Rituximab
- Keywords
- GB241, Rituximab, B-cell Lymphoma
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB241Biological
Single intravenous infusion (IV) 375 mg/m2
RituximabBiological
Single intravenous infusion (IV) 375 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| GB241 | Experimental | GB241:375 mg/m2, iv, one infusion Receives: Biological: GB241 |
| Rituximab | Active comparator | Rituximab: 375 mg/m2, iv, one infusion Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) for GB241 and rituximab concentrations
Measured: 85 days
Secondary outcomes (5)
AUC for GB241 and rituximab concentrations
Measured: 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Maximum observed concentration of the GB241 and rituximab
Measured: 85 days
Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
Measured: 85 days
Comparison of AEs between the two study arms
Measured: 85 days
Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start5 Jun 2017
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003039
- Sponsor's protocol ID
- GB241NHL1
- Status last verified
- Mar 2021
- First submitted
- 20 Dec 2016
- Last updated
- 23 Mar 2021
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03003039
- Acronym / sponsor ID
- GB241NHL1
- Conditions
- B-Cell Lymphoma
- Keywords
- GB241, Rituximab, B-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Nanjing Yoko Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 26 Dec 2016 (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 the area under the curve (AUC) for GB241 and rituximab concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB241 | Experimental | Biological: GB241GB241:375 mg/m2, iv, one infusion |
| Rituximab | Active comparator | Biological: RituximabRituximab: 375 mg/m2, iv, one infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- having histologically confirmed NHL expressing CD20 antigen
- having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
- signed an informed consent form which was approved by the institutional review board of the respective medical center
- aged from 18 to 75 years
- ECOG performance status of 0 to 1
Key exclusion criteria (13 listed)
- had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy
- participating in other clinical trial within 30 days before enrolment
- with serious hematologic dysfunction (white blood cell count of <3.0×103/uL; absolute neutrophil count of <1.5×103/ uL; platelet count of < 75×103/uL; hemoglobin level of < 8.0 g/dL); hepatic dysfunction (total bilirubin level of > 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN; renal dysfunction (serum creatinine level of > 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) > 1.5 × ULN (unless on therapeutic coagulation)
- had received live vaccine 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 |
|---|---|---|
| GB241Single intravenous infusion (IV) 375 mg/m2 | Biological | GB241 |
| RituximabSingle intravenous infusion (IV) 375 mg/m2 | Biological | Rituximab |
Primary outcome
Area under the curve (AUC) for GB241 and rituximab concentrations
Time frame: 85 days
5 secondary outcomes
AUC for GB241 and rituximab concentrations
Time frame: 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Maximum observed concentration of the GB241 and rituximab
Time frame: 85 days
Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
Time frame: 85 days
Comparison of AEs between the two study arms
Time frame: 85 days
Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms
Time frame: 85 days
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 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB241 and Rituximab in people with B-Cell Lymphoma, run by Nanjing Yoko Biomedical 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 6 inclusion and 13 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 Mar 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the curve (AUC) for GB241 and rituximab concentrations (time frame: 85 days). 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 Mar 2021.