RecruitingPhase 3NCT05040906
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
A Phase 3 study testing H02+CHOP and Rituxan +CHOP in people with Recruiting, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study. Primary objective: The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recruiting
- What is being tested?
- H02+CHOP and Rituxan +CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2020to 31 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated CD20-positive DLBCL confirmed.
- 18 years to 75 years; Male or female patients.
- IPI score of 1 to 2 and an ECOG performance status of 0 to 2.
- More than 6 months life expectancy.
- At least one measurable lymph node:
- For intranodal lesions, equal or greater than 1.5 cm in the long axis and equal or greater than 1.0 cm in the short diameter; For extranodal lesions, equal or greater than 1.0 cm in the long axis.
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- Adequate cardiac function (LVEF≥50%).
- Absolute neutrophil count(ANC) ≥1.5*109/L and platelet count(PLT) ≥75*109/L and hemoglobin ≥75g/L, total bilirubin level ≤1.5×upper limit of normal (ULN), aspartic acid Aminotransferase (AST), alanine aminotransferase (ALT)≤2.5×ULN, creatinine level (Cr)≤1.5×ULN.
- Signed an informed consent form which was approved by the institutional review board of the respective medical center.
Who cannot join
- Primary central nervous system(CNS) lymphoma, secondary CNS involvement, primary skin DLBCL (leg type), primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, and primary exudation Lymphoma, T-cell/histiocytosis-rich large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, lymphoma-like granuloma, EBV-positive mucosal skin ulcer, HHV8+DLBCL, NOS, primary testicular lymphomas.
- High-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangement diagnosed by fluorescence in situ hybridization (FISH).
- B-cell lymphoma has characteristics between DLBCL and classic HL, and cannot be divided into types.
- Transformed lymphoma. those who have transformed from other types of lymphomas, such as follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia/small B-cell lymphoma.
- History of other malignancy, except for skin basal cell carcinoma and cervical carcinoma in situ and has been in remission without treatment for >/= 5 years prior to enrolment.
- Severe mental illness.
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- Positive for HIV infection.
- Positive for HCV infection.
- Patients who have HBV (+) are eligible.
- History of anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
- Previous treatment for NHL, including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy or surgical treatment (except lymph node biopsies diagnostic surgery and biopsy).
- Participation in another clinical trial in the past 3 months.
- Vaccination with a attenuated live vaccine within 4 weeks.
- Use of hemopoietic cytokine in the past 2 weeks, e.g. granulocyte colony stimulating factor(G-CSF).
- Disease or symptom by the investigator's discretion(interstitial pneumonia, Uncontrollable systemic infections,severe cardiovascular disease (New York Heart Association functional class III or IV, myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, severe cardiac insufficiency, rogressive multifocal leukoencephalopathy), uncontrolled hypertension (SBP≥180mmHg and/or DBP≥100mmHg), active autoimmune diseases)
- Known hypersensitivity to any of the study drugs or its ingredients.
- Prior treatment with anthracycline.
- DLBCL invaded by special parts such as testis, breast, ovary, etc.
- Pregnant or lactating women.
- The researcher believes that it is not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong New Time Pharmaceutical Co., LTD
Linyi, Shandong, 276006
Shaohong Yin, 86-15265901803, yinshaohong@lunan.com.cn
About this study
Official title: A Phase 3, Randomized, Double-blind Study of H02 Plus CHOP Versus R-CHOP in Patients With Diffuse Large B-cell Lymphoma
This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study.
Primary objective:
The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of H02 combined with CHOP regimen and rituximab injection (Rituximab®) combined with CHOP regimen in the treatment of newly treated diffuse large B-cell lymphoma.
- Conditions
- Recruiting
- Being tested
- H02+CHOP, Rituxan +CHOP
- Keywords
- DLBCL, CD20, R-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H02+CHOPDrug
Drug:H02 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.
Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug:Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
Rituxan +CHOPDrug
Drug: Rituxan 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.
Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug: Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug : Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| H02+ Chemotherapy | Experimental | Participants received six cycles of H02(375 mg/m2) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles). Receives: Drug: H02+CHOP |
| Rituxan+Chemotherapy | Active comparator | Participants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles). Receives: Drug: Rituxan +CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(based on the evaluation of the IRC)
To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six periods of treatment.
Measured: 18 weeks
Secondary outcomes (6)
ORR(based on the judgment of the investigator)
Measured: 18 weeks
Complete response (CR) rate (based on the evaluation of the IRC and investigator)
CR was defined as the complete disappearance of all previously detectable disease signs. CR rate was percentage of participants with a CR event.
Measured: 18 weeks
1-year progression-free survival (PFS) rate
PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. The proportion of subjects without disease progression or death from any cause after randomization for one year.
Measured: 1 year
Duration of remission within 1 year (DOR)
The time from the first assessment of complete response or partial response to the first assessment of PD or death after randomization within 1 year.
Measured: 1 year
1-year overall survival (OS) rate
The proportion of subjects who did not die from any cause after randomization for 1 year.
Measured: 1 year
1-year event-free survival (EFS) rate
OS was defined as the time from randomization to death from any cause. Percentage of subjects without disease progression, death, or any interruption of treatment at 1 year of randomization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start13 Oct 2020
- Primary completion13 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitingStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040906
- Sponsor's protocol ID
- NTP-H02-Ⅰ-Ⅲ
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind Study of H02 Plus CHOP Versus R-CHOP in Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05040906
- Acronym / sponsor ID
- NTP-H02-Ⅰ-Ⅲ
- Conditions
- Recruiting
- Keywords
- DLBCL, CD20, R-CHOP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 13 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Sep 2021 (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 trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study.
Primary objective:
The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of H02 combined with CHOP regimen and rituximab injection (Rituximab®) combined with CHOP regimen in the treatment of newly treated diffuse large 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 |
|---|---|---|
| H02+ Chemotherapy | Experimental | Drug: H02+CHOPParticipants received six cycles of H02(375 mg/m2) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles). |
| Rituxan+Chemotherapy | Active comparator | Drug: Rituxan +CHOPParticipants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Untreated CD20-positive DLBCL confirmed.
- 18 years to 75 years; Male or female patients.
- IPI score of 1 to 2 and an ECOG performance status of 0 to 2.
- More than 6 months life expectancy.
- At least one measurable lymph node:
Key exclusion criteria (20 listed)
- Primary central nervous system(CNS) lymphoma, secondary CNS involvement, primary skin DLBCL (leg type), primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, and primary exudation Lymphoma, T-cell/histiocytosis-rich large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, lymphoma-like granuloma, EBV-positive mucosal skin ulcer, HHV8+DLBCL, NOS, primary testicular lymphomas.
- High-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangement diagnosed by fluorescence in situ hybridization (FISH).
- B-cell lymphoma has characteristics between DLBCL and classic HL, and cannot be divided into types.
- Transformed lymphoma. those who have transformed from other types of lymphomas, such as follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia/small B-cell lymphoma.
- History of other malignancy, except for skin basal cell carcinoma and cervical carcinoma in situ and has been in remission without treatment for >/= 5 years prior to enrolment.
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 |
|---|---|---|
| H02+CHOPDrug:H02 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug:Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle. | Drug | H02+ Chemotherapy |
| Rituxan +CHOPDrug: Rituxan 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug : Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle. | Drug | Rituxan+Chemotherapy |
Primary outcome
ORR(based on the evaluation of the IRC)
Time frame: 18 weeks
To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six periods of treatment.
6 secondary outcomes
ORR(based on the judgment of the investigator)
Time frame: 18 weeks
Complete response (CR) rate (based on the evaluation of the IRC and investigator)
Time frame: 18 weeks
1-year progression-free survival (PFS) rate
Time frame: 1 year
Duration of remission within 1 year (DOR)
Time frame: 1 year
1-year overall survival (OS) rate
Time frame: 1 year
1-year event-free survival (EFS) rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 H02+CHOP and Rituxan +CHOP in people with Recruiting, run by Shandong New Time Pharmaceutical 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 9 inclusion and 20 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 10 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jianfeng zhou, Doctor (13627284963, jfzhoutj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(based on the evaluation of the IRC) (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 10 Sep 2021.