Diffuse Large B-Cell LymphomaPhase 3NCT03670901
A Study to Compare the Efficacy and Safety of JHL1101 Versus Rituximab in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 3 study testing JHL1101 and MabThera in people with Diffuse Large B-Cell Lymphoma, run by JHL Biotech, Inc. at 1 site in China.
Trial summary
Approximately 500 subjects will be enrolled in this study. Subjects who meet the inclusion criteria will be randomized (1:1) into two groups. The study group will receive JHL1101 in combination with CHOP regimen, and the control group will receive rituximab (MabThera) in combination with CHOP. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- JHL1101 and MabThera
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2018to 7 Mar 2019
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated patients histopathologically or cytologically diagnosed with CD20-positive DLBCL;
- Aged ≥ 18 years and and ≤ 70 years of any gender;
- International Prognostic Index (IPI) for Lymphoma score of 0 - 2 points;
- Informed consent form has been signed before any specific study procedure is performed;
- At least one measurable lesion. Intranoal lesions are defined as: the long diameter is ≥ 1.5 cm and the short diameter is ≥ 1.0 cm; for extranodal lesions, the long diameter should be ≥ 1.0 cm;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 2;
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- The left ventricular ejection fraction (LVEF) measured by echocardiography is ≥ 50%;
- The patients have sufficient organ function, including:
- Absolute neutrophil count ≥ 15,000/ul; hemoglobin ≥ 80 g/L, platelet counts ≥ 75,000/uL;
- Total bilirubin level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Serum creatinine level ≤ 1.5 × ULN;
- Prothrombin time (PT) or activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≤ 1.5 × ULN in the absence of anticoagulant therapy;
- Men and women of childbearing age who have not undergone sterilization surgery must agree to practice effective contraception during the treatment period and within 12 months after the last administration of the study drug;
- Have an expected survival of at least 6 months as judged by the investigator.
Who cannot join
- Participated in other interventional clinical trials within three months prior to enrollment. Patients participating in non-interventional trials are eligible to participate in this study;
- Have received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colonystimulating factor (GM-CSF) for treatment within 14 days before enrollment;
- Patients who are or plan to be immunized with live virus vaccine within 28 days (or within 5 half-lives of the drug) before enrollment;
- Patients who underwent or plan to undergo major surgery within 28 days before enrollment, or patients whose surgical wounds have not healed;
- Patients who are receiving continuous corticosteroid treatment, with > 30 mg/day prednisone or equivalent dose of corticosteroids for ≥ 10 days of continuous treatment;
- Have a history of gastrointestinal perforation and/or fistula within 6 months before enrollment;
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- Known to be allergic to monoclonal antibody (mAb) therapy or rituximab,or patients with known sensitivity or allergy to murine products;
- Patients who have contraindications to any component of the CHOP regimen;
- Have previously received treatment for DLBCL, including:
- chemotherapy, immunotherapy, local radiotherapy for lymphoma, surgical treatment (except for tumor or pathologic biopsy and surgical resection not for lymphoma), and any monoclonal antibody therapy within 3 months prior to enrollment;
- Have previously received cytotoxic drugs or anti-CD20 monoclonal antibody therapy for other diseases (such as rheumatoid arthritis);
- Have a history of other malignancies that may affect study protocol compliance or result analysis;
- Also suffering from severe non-malignant diseases that can affect study protocol compliance, such as severe cardiovascular diseases, uncontrolled diabetes and hypertension, peripheral nervous system or central nervous system diseases;
- Known to have uncontrollable active infectious diseases or any major infection events (other than neoplastic fever) requiring intravenous antibiotic treatment or hospitalization within four weeks prior to enrollment;
- Subjects known to be positive for human immunodeficiency virus (HIV) antibody;
- Positive for hepatitis C virus (HCV) antigen or antibody;
- Patients with HBs Ag(＋), and his/her HBV-DNA level is>103 copies;
- The investigator believes the subject is unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multinational, Randomized, Double-blind, Positive-controlled, Parallel Study to Compare the Efficacy and Safety of JHL1101 in Combination With CHOP (J-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
Approximately 500 subjects will be enrolled in this study. Subjects who meet the inclusion criteria will be randomized (1:1) into two groups. The study group will receive JHL1101 in combination with CHOP regimen, and the control group will receive rituximab (MabThera) in combination with CHOP. The dose of 375 mg/m2 is given intravenously on Day 1 (D1) of each cycle, and CHOP regimen is administered after the infusion of JHL1101 or rituximab is completed. Efficacy evaluation will be performed at baseline, after 3 cycles treatment (D18± 2 of Cycle 3, before the next cycle of treatment) and after 6 cycles treatment (D21±3 of Cycle 6). Subjects evaluated as progressive disease (PD) should be withdrawn from the study treatment and their subsequent treatments will be determined by the investigator. The analysis of primary endpoint is the ORR over the 6-cycle treatment period.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- JHL1101, MabThera
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JHL1101Biological
JHL1101, 100mg/10mL
MabTheraBiological
Rituximab, 100mg/10mL
| Study group | Role | What they receive |
|---|---|---|
| JHL1101 | Experimental | 375 mg/m2 of JHL1101 is given intravenously on D1 of each cycle Receives: Biological: JHL1101 |
| MabThera | Active comparator | 375 mg/m2 of Rituximab is given intravenously on D1 of each cycle Receives: Biological: MabThera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
To compare the overall response rate after 6 cycles treatment
Measured: 18 weeks
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 start13 Nov 2018
- Primary completion7 Mar 2019
- Study completion7 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 Diffuse Large 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHL Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Zhu, MD/PhD, Principal investigator, Beijing Cancer Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670901
- Sponsor's protocol ID
- JHL-CLIN-1101-03
- 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 Multinational, Randomized, Double-blind, Positive-controlled, Parallel Study to Compare the Efficacy and Safety of JHL1101 in Combination With CHOP (J-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT03670901
- Acronym / sponsor ID
- JHL-CLIN-1101-03
- Conditions
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The development was stopped due to company's strategy consideration
- Enrolment
- 8 participants (actual)
- Lead sponsor
- JHL Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 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.
Approximately 500 subjects will be enrolled in this study. Subjects who meet the inclusion criteria will be randomized (1:1) into two groups. The study group will receive JHL1101 in combination with CHOP regimen, and the control group will receive rituximab (MabThera) in combination with CHOP. The dose of 375 mg/m2 is given intravenously on Day 1 (D1) of each cycle, and CHOP regimen is administered after the infusion of JHL1101 or rituximab is completed. Efficacy evaluation will be performed at baseline, after 3 cycles treatment (D18± 2 of Cycle 3, before the next cycle of treatment) and after 6 cycles treatment (D21±3 of Cycle 6). Subjects evaluated as progressive disease (PD) should be withdrawn from the study treatment and their subsequent treatments will be determined by the investigator. The analysis of primary endpoint is the ORR over the 6-cycle treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JHL1101 | Experimental | Biological: JHL1101375 mg/m2 of JHL1101 is given intravenously on D1 of each cycle |
| MabThera | Active comparator | Biological: MabThera375 mg/m2 of Rituximab is given intravenously on D1 of each cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Previously untreated patients histopathologically or cytologically diagnosed with CD20-positive DLBCL;
- Aged ≥ 18 years and and ≤ 70 years of any gender;
- International Prognostic Index (IPI) for Lymphoma score of 0 - 2 points;
- Informed consent form has been signed before any specific study procedure is performed;
- At least one measurable lesion. Intranoal lesions are defined as: the long diameter is ≥ 1.5 cm and the short diameter is ≥ 1.0 cm; for extranodal lesions, the long diameter should be ≥ 1.0 cm;
Key exclusion criteria (18 listed)
- Participated in other interventional clinical trials within three months prior to enrollment. Patients participating in non-interventional trials are eligible to participate in this study;
- Have received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colonystimulating factor (GM-CSF) for treatment within 14 days before enrollment;
- Patients who are or plan to be immunized with live virus vaccine within 28 days (or within 5 half-lives of the drug) before enrollment;
- Patients who underwent or plan to undergo major surgery within 28 days before enrollment, or patients whose surgical wounds have not healed;
- Patients who are receiving continuous corticosteroid treatment, with > 30 mg/day prednisone or equivalent dose of corticosteroids for ≥ 10 days of continuous treatment;
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 |
|---|---|---|
| JHL1101JHL1101, 100mg/10mL | Biological | JHL1101 |
| MabTheraRituximab, 100mg/10mL | Biological | MabThera |
Primary outcome
Overall response rate (ORR)
Time frame: 18 weeks
To compare the overall response rate after 6 cycles treatment
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.
Jun Zhu, MD/PhD principal investigator
Beijing Cancer Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JHL1101 and MabThera in people with Diffuse Large B-Cell Lymphoma, run by JHL Biotech, Inc. 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 14 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: 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall response rate (ORR) (time frame: 18 weeks). 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.