B Cell LymphomaPhase 1NCT03670888
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
A Phase 1 study testing JHL1101 and Rituximab in people with B Cell Lymphoma, run by JHL Biotech, Inc. at 2 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. 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?
- JHL1101 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesChina
- Study dates
- 16 Nov 2018to 19 Mar 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
- CD20-positive B-cell lymphoma.
- Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
- 18 years to 75 years
- Signed an informed consent
- Adequate organ function, including the following
- Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL
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- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN
- Serum creatinine ≤ 1.5 times the ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Chemotherapy: must not have received within 8 weeks of entry onto this study
- Radiotherapy: must not have received within 4 weeks of entry onto this study
- Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia
- Aagreement to practice contraception
- More than 6 months life expectancy.
Who cannot join
- Received any investigational drug within 28 days prior to study enrollment
- Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment
- Received previous immunotherapy
- Received or plan to receive a live vaccine within 28 days of study enrollment
- Major surgery within 28 days of study enrollment
- Received systemic steroid therapy with 28 days of study enrollment
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- Received or plan to receive the hematopoietic cell transplant
- History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment
- Known allergic reactions against monoclonal antibody or rituximab.
- Received rituximab or other anti-CD20 monoclonal antibody
- Blood concentration of rituximab > 10 ug/mL during screen visit
- Human immunodeficiency virus (HIV) positive
- Hepatitis C virus (HCV) antigen and antibody positive
- Hepatitis B virus surface antigen (HBsAg) positive
- Body Mass Index (MBI) ≥ 28 kg/m2
Trial locations and contacts
2 sites in 1 country.
China2 sites
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality
About this study
Official title: "A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients"
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.
- Conditions
- B Cell Lymphoma
- Being tested
- JHL1101, 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.
JHL1101Biological
100 mg/10 mL solution in a single-use vial
RituximabBiological
100 mg/10 mL solution in a single-use vial
| Study group | Role | What they receive |
|---|---|---|
| JHL1101 | Experimental | Single dose IV infusion of 375 mg/m2 of JHL1101 Receives: Biological: JHL1101 |
| Rituxan | Active comparator | Single dose IV infusion of 375 mg/m2 of Rituximab Receives: Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0~t
Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration
Measured: 91 days
Secondary outcomes (2)
AUC0-∞
AUC from time 0 of the first infusion on Day 1 extrapolated to infinity
Measured: 91 days
Cmax
Maximum concentration after infusion
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 posted14 Sep 2018
- Study start16 Nov 2018
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Why it stopped: The development was stopped due to company's strategy consideration
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHL Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu-Gui Qiu, MD, Principal investigator, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670888
- Sponsor's protocol ID
- JHL-CLIN-1101-02
- Status last verified
- Jan 2020
- First submitted
- 12 Sep 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Multicenter, Randomized, Double-blind, Parallel-controlled Trial to Compare the Bioequivalence and Safety of the Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody Injection (JHL1101) and Rituximab Injection in CD20 Positive B Cell Lymphoma Patients"
- ClinicalTrials.gov ID
- NCT03670888
- Acronym / sponsor ID
- JHL-CLIN-1101-02
- Conditions
- B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development was stopped due to company's strategy consideration
- Enrolment
- 1 participants (actual)
- Lead sponsor
- JHL Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 14 Sep 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.
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JHL1101 | Experimental | Biological: JHL1101Single dose IV infusion of 375 mg/m2 of JHL1101 |
| Rituxan | Active comparator | Biological: RituximabSingle dose IV infusion of 375 mg/m2 of Rituximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- CD20-positive B-cell lymphoma.
- Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
- 18 years to 75 years
- Signed an informed consent
- Adequate organ function, including the following
Key exclusion criteria (15 listed)
- Received any investigational drug within 28 days prior to study enrollment
- Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment
- Received previous immunotherapy
- Received or plan to receive a live vaccine within 28 days of study enrollment
- Major surgery within 28 days of study enrollment
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 |
|---|---|---|
| JHL1101100 mg/10 mL solution in a single-use vial | Biological | JHL1101 |
| Rituximab100 mg/10 mL solution in a single-use vial | Biological | Rituxan |
Primary outcome
AUC0~t
Time frame: 91 days
Area under the concentration-time curve (AUC) from time 0 (predose) of the first infusion on Day 1 to the last quantifiable concentration
2 secondary outcomes
AUC0-∞
Time frame: 91 days
Cmax
Time frame: 91 days
Results and safety
The study was stopped early (reason given: The development was stopped due to company's strategy consideration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Lu-Gui Qiu, MD principal investigator
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JHL1101 and Rituximab in people with B Cell Lymphoma, run by JHL Biotech, Inc. 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 14 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: stopped early, as of the sponsor's last update on 9 Jan 2020. 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 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 was stopped early (reason given: The development was stopped due to company's strategy consideration). Results are not available in the source record.
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?
AUC0~t (time frame: 91 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 9 Jan 2020.