B-cell Non Hodgkin's LymphomaPhase 1/2NCT02584920
A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma
A Phase 1/2 study testing HLX01 and Rituximab in people with B-cell Non Hodgkin's Lymphoma, run by Shanghai Henlius Biotech.
Trial summary
Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01 and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- B-cell Non Hodgkin's Lymphoma
- What is being tested?
- HLX01 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Aug 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged from 18 to 65 years;
- CD20-positive non-Hodgkin's lymphoma (NHL);
- having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
- ECOG performance status of <=1, expected survival of at least >= 3 months;
- Peripheral blood lymphocyte count < 5×10^9/L
- signed an informed consent form which was approved by the institutional review board of the respective medical center .
Who cannot join
- Other invasive malignancies within 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix;
- Chemotherapy within 1 month;
- Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 month before enrollment;
- Had received rituximab or other anti-CD20(+) monoclonal antibody treatment 1 month ago but with ADA(+) before enrollment;
- Blood concentration of Rituximab> 24 μg/ml prior to study entry;
- Had received hematopoitic growth factor within 1 week prior to study entry;
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- Receipt of a live/attenuated vaccine within 4 weeks prior to the Screening Visit;
- Recent major surgery (within 8 weeks prior to screening, excluding lymph node biopsy);
- Peripheral or central nervous system disease;
- Serious hematologic dysfunction (white blood cell count of <3.0×109/L; absolute neutrophil count of <1.5×109/L; platelet count of < 100×109/L; hemoglobin level of < 9.0 g/dL);
- 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; alkaline phosphatase > 3.0 × ULN; renal dysfunction (serum creatinine level of > 1.5×ULN );
- Abnormal thyroid function;
- Seropositive for HIV , HCV antibody; seropositive for hepatitis B virus surface antigen (HBsAg). HBV DNA>1.0×103copies/ml;
- Serious underlying medical conditions, could impair the ability of the patient to participate in the trial (including but not limited to ongoing active infection, uncontrolled diabetes mellitus, significant cardiac disease, uncontrolled angina, gastric ulcers, active autoimmune disease);
- Pregnancy or breast feeding. For women of childbearing potential.
- History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug.
- Subjects had a history of alcoholism or drug abuse;
- Researchers think that do not fit into the group.
About this study
Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01 and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.
- Conditions
- B-cell Non Hodgkin's Lymphoma
- Being tested
- HLX01, Rituximab
- 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.
HLX01Drug
RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| HLX01 | Experimental | 375mg/m2 iv single dose Receives: Drug: HLX01 |
| Rituximab | Active comparator | 375mg/m2 iv single dose Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) for HLX01 and rituximab concentrations
Measured: 91 days
Secondary outcomes (3)
The Maximum Concentration (Cmax) of the HLX01 and rituximab
Measured: 91 days
Presence of Anti-Drug Antibodies against HLX01
Measured: 91 days
Change from baseline of CD19+ B-cells
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell Non Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584920
- Sponsor's protocol ID
- HLX01-NHL02
- Status last verified
- May 2022
- First submitted
- 21 Oct 2015
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shi Y, Zhang Q, Han X, Qin Y, Ke X, Su H, Liu L, Fu J, Jin J, Feng J, Hong X, Zhang X, Wu D, Jiang B, Dong X. Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma. Chin J Cancer Res. 2021 Jun 30;33(3):405-416. doi: 10.21147/j.issn.1000-9604.2021.03.11.
PubMed 34321836
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02584920
- Acronym / sponsor ID
- HLX01-NHL02
- Conditions
- B-cell Non Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Oct 2015 (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.
Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01 and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX01 | Experimental | Drug: HLX01375mg/m2 iv single dose |
| Rituximab | Active comparator | Drug: Rituximab375mg/m2 iv single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged from 18 to 65 years;
- CD20-positive non-Hodgkin's lymphoma (NHL);
- having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
- ECOG performance status of <=1, expected survival of at least >= 3 months;
- Peripheral blood lymphocyte count < 5×10^9/L
Key exclusion criteria (18 listed)
- Other invasive malignancies within 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix;
- Chemotherapy within 1 month;
- Had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 month before enrollment;
- Had received rituximab or other anti-CD20(+) monoclonal antibody treatment 1 month ago but with ADA(+) before enrollment;
- Blood concentration of Rituximab> 24 μg/ml 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 |
|---|---|---|
| HLX01 | Drug | HLX01 |
| Rituximab | Drug | Rituximab |
Primary outcome
Area under the curve (AUC) for HLX01 and rituximab concentrations
Time frame: 91 days
3 secondary outcomes
The Maximum Concentration (Cmax) of the HLX01 and rituximab
Time frame: 91 days
Presence of Anti-Drug Antibodies against HLX01
Time frame: 91 days
Change from baseline of CD19+ B-cells
Time frame: 91 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 9 May 2022.
- Results publication: PubMed 34321836Shi Y, Zhang Q, Han X, Qin Y, Ke X, Su H, Liu L, Fu J, Jin J, Feng J, Hong X, Zhang X, Wu D, Jiang B, Dong X. Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma. Chin J Cancer Res. 2021 Jun 30;33(3):405-416. doi: 10.21147/j.issn.1000-9604.2021.03.11.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HLX01 and Rituximab in people with B-cell Non Hodgkin's Lymphoma, run by Shanghai Henlius Biotech.
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 18 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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 HLX01 and rituximab concentrations (time frame: 91 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02584920, which also lists 1 linked publication.
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 9 May 2022.