Non-hodgkin's LymphomaPhase 1/2NCT03456466
Study of TQB2303 in Patients With Aggressive CD20 Positive Non-Hodgkin's Lymphoma
A Phase 1/2 study testing TQB2303 and Rituximab in people with Non-hodgkin's Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
Primary Outcome Measures: Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ] Secondary Outcome Measures: The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The area under the plasma concentration-time curve from 0 to inf (infinite) time… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-hodgkin's Lymphoma
- What is being tested?
- TQB2303 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Phase 1/2
- 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 should participate in the study voluntarily and sign informed consent;
- CD20-positive non-Hodgkin's lymphoma (NHL)：Diffuse Large B-cell Lymphoma；Mantle Cell Lymphoma；Follicular Lymphoma；Marginal Zone Lymphoma;
- having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;And the investigators believe that CD20-positive B-cell NHL patients can benefit from anti-CD20 monoclonal antibody therapy;
- aged from 18 to 75 years;
- ECOG PS:0-1；
- Life expectancy of more than 3 months
Who cannot join
- Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
- patients who were treated with antitumor therapy (including corticosteroid therapy) within 4 weeks prior to enrollment, or who had not recovered from the toxicity of the previous treatment;
- Patients who participated in other clinical studies within 30 days ;
- Serious hematologic dysfunction (white blood cell count of <3.0×10^9/L; absolute neutrophil count of <1.5×10^9/L; platelet count of < 75×10^9/L; hemoglobin level of <80g/L); In the absence of anticoagulant therapy, International Standardization Ratio (INR)> 1.5× ULN;Partial prothrombin time (PTT)Or activated partial thromboplastin time (aPTT)> 1.5 × ULN;) Hepatic dysfunction (total bilirubin level of > 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN;) renal dysfunction (serum creatinine level of > 1.5×ULN );
- Other invasive malignancies except for cured the IB or lower level of cervical cancer; Non-invasive basal cells or squamous cell skin cancer; Get CR> 10 years of breast cancer;Get CR> 10 years of malignant melanoma;or other malignancies with CR> 5 years;
- Central nervous system (CNS) lymphoma, AIDS-associated lymphoma;
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- Active infections and other serious non-malignant tumor diseases, Such as Qualitative pneumonia, Severe organic cardiovascular disease, Heart conduction block > 2,Myocardial infarction in 6 months, Cerebral infarction in 3 months,Cerebral hemorrhage,Thyroid dysfunction (TSH lower than the normal lower limit or higher than the upper limit of normal, and the researchers have a clinical significance);
- Seropositive for HIV , HCV antibody; Or one of the following HBV findings :
- HBsAg positive;
- HBsAg negative, HBcAb positive and HBV DNA positive;
- Plan major surgery, or surgical wound unhealed patients;
- History of severe allergies, protein products and mouse products such as allergies;
- Pregnancy or breast feeding. Companion for women of childbearing age or women of childbearing age,who reluctant to take appropriate contraceptive methods within one year after the last treatment of the study;Pregnancy before pregnancy screening, the women who blood / urine results were positive;
- Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
- Researchers think that do not fit into the group.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jifeng feng, doctor, 025-83233303, fjif@vip.sina.com
- Recruiting
First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215006
Depei wu, doctor, 0512-67780040, drwudepei@163.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel Control Clinical Trial to Assess the Similarity of the Safety and Pharmacokinetics of TQB2303 in Combination With Rituximab to Patients With AggressiveCD20 Positive Non-Hodgkin's Lymphoma
Primary Outcome Measures:
Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ]
Secondary Outcome Measures:
The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).
- Conditions
- Non-hodgkin's Lymphoma
- Being tested
- TQB2303, Rituximab
- 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.
TQB2303Drug
375mg/m2 ，iv
RituximabDrug
375mg/m2 ，iv
| Study group | Role | What they receive |
|---|---|---|
| TQB2303 | Experimental | Not described Receives: Drug: TQB2303 |
| Rituximab | Active comparator | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the curve (AUC) forTQB2303 and rituximab concentrations
Measured: 85 days
Cmax
The Maximum Concentration (Cmax) of the TQB2303 and rituximab
Measured: 85 days
AUC0-∞
The area under the plasma concentration-time curve from 0 to inf (infinite) time
Measured: 85 days
Tmax
The time to reach the maximum plasma concentration after treatment
Measured: 85 days
CL
Total clearance
Measured: 85 days
t1/2
Elimination of half-life
Measured: 85 days
Vd
Apparent distribution volume
Measured: 85 days
Secondary outcomes (2)
Evaluation of immunogenicity
Anti-drug antibody (ADA), neutralizing antibody (Nab detection when ADA positive)
Measured: 85 days
Change of CD19+ CD20+ B-cells from baseline
Change of CD19+ CD20+ B-cells from baseline
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 posted7 Mar 2018
- Study start1 May 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin's LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TQB2303 and Rituximab
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
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
- NCT03456466
- Sponsor's protocol ID
- TQB2303-I-01
- Status last verified
- Mar 2018
- First submitted
- 23 Dec 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel Control Clinical Trial to Assess the Similarity of the Safety and Pharmacokinetics of TQB2303 in Combination With Rituximab to Patients With AggressiveCD20 Positive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03456466
- Acronym / sponsor ID
- TQB2303-I-01
- Conditions
- Non-hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 7 Mar 2018 (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.
Primary Outcome Measures:
Area under the curve (AUC) forTQB2303 and rituximab concentrations [ Time Frame: 85 days ]
Secondary Outcome Measures:
The Maximum Concentration (Cmax) of the TQB2303 and rituximab [ Time Frame: 85 days ] The area under the plasma concentration-time curve from 0 to inf (infinite) time (AUC0-∞); The time to reach the maximum plasma concentration after treatment (Tmax) Total clearance (CL); Elimination of half-life (t1 / 2); Apparent distribution volume (Vd).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- TQB2303 and Rituximab
| Arm | Type | Receives |
|---|---|---|
| TQB2303 | Experimental | Drug: TQB2303 |
| Rituximab | Active comparator | Drug: Rituximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should participate in the study voluntarily and sign informed consent;
- CD20-positive non-Hodgkin's lymphoma (NHL)：Diffuse Large B-cell Lymphoma；Mantle Cell Lymphoma；Follicular Lymphoma；Marginal Zone Lymphoma;
- having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;And the investigators believe that CD20-positive B-cell NHL patients can benefit from anti-CD20 monoclonal antibody therapy;
- aged from 18 to 75 years;
- ECOG PS:0-1；
Key exclusion criteria (15 listed)
- Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment;
- patients who were treated with antitumor therapy (including corticosteroid therapy) within 4 weeks prior to enrollment, or who had not recovered from the toxicity of the previous treatment;
- Patients who participated in other clinical studies within 30 days ;
- Serious hematologic dysfunction (white blood cell count of <3.0×10^9/L; absolute neutrophil count of <1.5×10^9/L; platelet count of < 75×10^9/L; hemoglobin level of <80g/L); In the absence of anticoagulant therapy, International Standardization Ratio (INR)> 1.5× ULN;Partial prothrombin time (PTT)Or activated partial thromboplastin time (aPTT)> 1.5 × ULN;) Hepatic dysfunction (total bilirubin level of > 1.5 × upper limit of normal (ULN); aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN;) renal dysfunction (serum creatinine level of > 1.5×ULN );
- Other invasive malignancies except for cured the IB or lower level of cervical cancer; Non-invasive basal cells or squamous cell skin cancer; Get CR> 10 years of breast cancer;Get CR> 10 years of malignant melanoma;or other malignancies with CR> 5 years;
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 |
|---|---|---|
| TQB2303375mg/m2 ，iv | Drug | TQB2303 |
| Rituximab375mg/m2 ，iv | Drug | Rituximab |
Primary outcome
AUC
Time frame: 85 days
Area under the curve (AUC) forTQB2303 and rituximab concentrations
Cmax
Time frame: 85 days
The Maximum Concentration (Cmax) of the TQB2303 and rituximab
AUC0-∞
Time frame: 85 days
The area under the plasma concentration-time curve from 0 to inf (infinite) time
Tmax
Time frame: 85 days
The time to reach the maximum plasma concentration after treatment
CL
Time frame: 85 days
Total clearance
t1/2
Time frame: 85 days
Elimination of half-life
Vd
Time frame: 85 days
Apparent distribution volume
2 secondary outcomes
Evaluation of immunogenicity
Time frame: 85 days
Change of CD19+ CD20+ B-cells from baseline
Time frame: 85 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2303 and Rituximab in people with Non-hodgkin's Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group 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 6 inclusion and 15 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 7 Mar 2018. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 85 days). The study lists 7 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 7 Mar 2018.