Diffuse Large B-cell LymphomaPhase 2Hi-CHOPNCT03485118
RHCACD20MA (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
A Phase 2 study testing HS006+CHOP and Rituximab+CHOP in people with Diffuse Large B-cell Lymphoma, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
Trial summary
Primary objective: To evaluate the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) versus Rituximab with CHOP (R-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma as first line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- HS006+CHOP and Rituximab+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
- 137 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2016to 14 Jan 2018
- Phase
- Phase 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
- previously untreated. CD20 Positive DLBCL.
- Lymphoma International PrognosisIndex (IPI) score of 0-3, stage I-IV.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, Expected survival>6 months.
- At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter ≥1.5cm and short axis ≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm.
- CBC: WBC >4 x 10^9/L;NEU > 2 x 10^9 / L; PLT > 100 x 10^9 / L; Patients with bone marrow infiltration: WBC≥3 x 10^9/L、HGB≥80g/L、NEU≥1.5 x 10^9/L、PLT≥75 x 10^9/L；
- hepatic function: TBIL≤1.5 x ULN；ALT or AST ≤2.5 x ULN； ALP≤3 x ULN if with no bone marrow infiltration;Renal function: Cr≤1.5 x ULN；
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- HIV negative;
- HCV-Ab negative OR HCV-Ab positive but HCV-RNA negative.
- HBsAg and HBcAb negative,HBsAg or HBcAb positive with HBV DNA<1×1000IU / ml.
- Cardiac echocardiography :LVEF ≥ 50%;
- Must agree to take effective birth control methods or are not of childbearing potential. Women must agree to continue contraceptive measures within 12 months after the last treatment. Men must agree to continue contraception within 3 months after the treatment.
- All patients must have signed an informed consent document.
Who cannot join
- Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system or B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma, orB-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma, or primary mediastinal thymic large B-cell lymphomas or primary effusion lymphoma or plasmablastic lymphoma or primary cutaneous DLBCL,leg type or ALK+large B-cell lymphoma or transformed lymphoma or primary testicular DLBCL.
- Confirmed DLBCL with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH. BCL-2 ≥ 70% positive and c-MYC ≥ 40% positive and according to Han's immunohistochemistry method, tumor type is GCB but unable to get unequivocal FISH result.
- 3．History of other cancers( excluding squamous cell carcinoma of skin, basal cell carcinoma of skin, carcinoma in situ of cervix) within 5 years prior to the enrollment of the study.
- 4.Patients who received major surgeries (excluding diagnostic surgeries) within 2 months prior to the enrollment of the study.
- 5. Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy); 6.Patients who received cytotoxic drugs or anti-CD20 monoclonal antibody for other diseases (such as Rheumatoid arthritis).
- 7. Patients who received any monoclonal antibody within 3 months prior to the enrollment of the study.
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- 8. Patients who participated in other clinical trials within 3 months prior to the enrollment of the study.
- 9. Patients who received attenuated or live virus vaccine within 1 months prior to the enrollment of the study.
- 10. Patients who received hematopoietic stimulating factors within 2 weeks prior to the enrollment of the study.
- 11. Patients who received prednisone>30 mg per day or equivalent corticosteroids for controlling the symptoms other than lymphoma; Patients who received prednisone≤30 mg per day or equivalent corticosteroids should receive stable dose for at least 4 weeks before randomization by written record.
- 13. Patients with peripheral nervous system or central nervous system disease. 14. Suspected active or latent tuberculosis infections. 15. Within 4 months prior to the enrollment of the study, Patients had active bacteria, virus, fungi, mycobacteria,parasites or other infections(excluding nail bed fungal infection) or in need of intravenous antibiotic treatment or with sever systemic infection or in need of inpatient admission hospital(except for the treatment of neoplastic fever).
- 16. Other serious diseases that may impair the ability of subjects' participation(e.g., uncontrollable diabetes, (severe cardiac dysfunction, history of myocardial infarction or unstable arrhythmias or unstable angina within the past 6 months or gastric ulcer (gastric ulcer with risk of perforation) or active autoimmune disease or severe hypertension, etc.).
- 17. Contraindicative to any drug in CHOP, or to anthracycline;Patients with diabetes and intolerant to the prednisone in this study.
- 18. History of alcohol abuse or drug abuse. 19. Susceptible to allergies or allergic to anyactive ingredients or excipients in the trial (including CHOP) or murine source products ormedication (including CHOP) including active ingredients or excipients or rat source products or heterogeneous proteins.
- 20. Patients with serious mental disease. 21. Patients who are lack of compliance during the trial and/or the follow-up phase.
- 22. Patients that researchers deem as not appropriate to enter the study.
About this study
Official title: Phase II Study on Safety and Efficacy of Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Primary objective:
To evaluate the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) versus Rituximab with CHOP (R-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma as first line treatment.
Secondary objective:
To evaluate the safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma.
To study the pharmacokinetics of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) in patients with previously untreated Diffuse Large B-cell Lymphoma.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- HS006+CHOP, Rituximab+CHOP
- Keywords
- Previously untreated DLBCL
- 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.
HS006+CHOPDrug
Drug:HS006 HS006 375 mg per square meter (mg/m^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.
Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
HS006+CHOPDrug
Drug:HS006 HS006 500 mg per square meter (mg/m^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. During cycle 1,HS006 also infused on Day 8 and 15.
Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug: Prednisone Prednisone 100 mg administered orally on Days 1-5 of each 21-day cycle.
Rituximab+CHOPDrug
Drug:Rituxan Rituxan 375 mg per square metre (mg/m^2), administered by intravenous (IV) on Day 1 of each 21-day cycle.
Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| HS006+Chemotherapy | Experimental | 1. Participants received six 21-day cycles of HS006(375 mg per square meter) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles).
2. Participants received six 21-day cycles of HS006(500 mg per square meter) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles). Receives: Drug: HS006+CHOP |
| Rituxan+Chemotherapy | Active comparator | Participants received six 21-day cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles). Receives: Drug: Rituximab+CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start12 May 2016
- Primary completion12 Aug 2016
- Study completion14 Jan 2018
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, controlled, multicenter phase II study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485118
- Sponsor's protocol ID
- HISUN-CD20-2016L01
- Acronym
- Hi-CHOP
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on Safety and Efficacy of Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody (HS006) Combined With CHOP (Hi-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03485118
- Acronym / sponsor ID
- Hi-CHOP / HISUN-CD20-2016L01
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Previously untreated DLBCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2016 (actual)
- Primary completion
- 12 Aug 2016 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 2 Apr 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 objective:
To evaluate the efficacy of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) versus Rituximab with CHOP (R-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma as first line treatment.
Secondary objective:
To evaluate the safety of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) with CHOP(Hi-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma.
To study the pharmacokinetics of recombinant human-mouse chimeric anti-CD20 monoclonal antibody injection(HS006) in patients with previously untreated Diffuse Large B-cell Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind, controlled, multicenter phase II study.
| Arm | Type | Receives |
|---|---|---|
| HS006+Chemotherapy | Experimental | Drug: HS006+CHOP1. Participants received six 21-day cycles of HS006(375 mg per square meter) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone/prednisolone(CHOP) chemotherapy(21-day cycles). 2. Participants received six 21-day cycles of HS006(500 mg per square meter) combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles). |
| Rituxan+Chemotherapy | Active comparator | Drug: Rituximab+CHOPParticipants received six 21-day 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 (12 listed)
- previously untreated. CD20 Positive DLBCL.
- Lymphoma International PrognosisIndex (IPI) score of 0-3, stage I-IV.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, Expected survival>6 months.
- At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter ≥1.5cm and short axis ≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm.
- CBC: WBC >4 x 10^9/L;NEU > 2 x 10^9 / L; PLT > 100 x 10^9 / L; Patients with bone marrow infiltration: WBC≥3 x 10^9/L、HGB≥80g/L、NEU≥1.5 x 10^9/L、PLT≥75 x 10^9/L；
Key exclusion criteria (16 listed)
- Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system or B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma, orB-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma, or primary mediastinal thymic large B-cell lymphomas or primary effusion lymphoma or plasmablastic lymphoma or primary cutaneous DLBCL,leg type or ALK+large B-cell lymphoma or transformed lymphoma or primary testicular DLBCL.
- Confirmed DLBCL with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH. BCL-2 ≥ 70% positive and c-MYC ≥ 40% positive and according to Han's immunohistochemistry method, tumor type is GCB but unable to get unequivocal FISH result.
- 3．History of other cancers( excluding squamous cell carcinoma of skin, basal cell carcinoma of skin, carcinoma in situ of cervix) within 5 years prior to the enrollment of the study.
- 4.Patients who received major surgeries (excluding diagnostic surgeries) within 2 months prior to the enrollment of the study.
- 5. Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy); 6.Patients who received cytotoxic drugs or anti-CD20 monoclonal antibody for other diseases (such as Rheumatoid arthritis).
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 |
|---|---|---|
| HS006+CHOPDrug:HS006 HS006 375 mg per square meter (mg/m^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle. | Drug | HS006+Chemotherapy |
| HS006+CHOPDrug:HS006 HS006 500 mg per square meter (mg/m^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. During cycle 1,HS006 also infused on Day 8 and 15. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 1-5 of each 21-day cycle. | Drug | HS006+Chemotherapy |
| Rituximab+CHOPDrug:Rituxan Rituxan 375 mg per square metre (mg/m^2), administered by intravenous (IV) on Day 1 of each 21-day cycle. Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle. Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle. | Drug | Rituxan+Chemotherapy |
Primary outcome
ORR
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.
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 2 Apr 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.
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 2 study testing HS006+CHOP and Rituximab+CHOP in people with Diffuse Large B-cell Lymphoma, run by Zhejiang Hisun Pharmaceutical Co. Ltd..
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 12 inclusion and 16 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 2 Apr 2018. 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 phase mean?
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?
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 2 Apr 2018.