A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
Primary Purpose
Recruiting
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
H02+CHOP
Rituxan +CHOP
Sponsored by
About this trial
This is an interventional treatment trial for Recruiting focused on measuring DLBCL, CD20, R-CHOP
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria
- 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.
- 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.
Sites / Locations
- Shandong New Time Pharmaceutical Co., LTDRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
H02+ Chemotherapy
Rituxan+Chemotherapy
Arm Description
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).
Participants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
ORR(based on the judgment of the investigator)
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.
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.
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.
1-year overall survival (OS) rate
The proportion of subjects who did not die from any cause after randomization for 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
Full Information
NCT ID
NCT05040906
First Posted
September 7, 2021
Last Updated
September 7, 2021
Sponsor
Shandong New Time Pharmaceutical Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT05040906
Brief Title
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
Official Title
A Phase 3, Randomized, Double-blind Study of H02 Plus CHOP Versus R-CHOP in Patients With Diffuse Large B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong New Time Pharmaceutical Co., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recruiting
Keywords
DLBCL, CD20, R-CHOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
H02+ Chemotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Rituxan+Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles).
Intervention Type
Drug
Intervention Name(s)
H02+CHOP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituxan +CHOP
Intervention Description
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.
Primary Outcome Measure Information:
Title
ORR(based on the evaluation of the IRC)
Description
To evaluate the objective response rate (ORR) in patients with previously untreated Diffuse Large B-cell Lymphoma after six periods of treatment.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
ORR(based on the judgment of the investigator)
Time Frame
18 weeks
Title
Complete response (CR) rate (based on the evaluation of the IRC and investigator)
Description
CR was defined as the complete disappearance of all previously detectable disease signs. CR rate was percentage of participants with a CR event.
Time Frame
18 weeks
Title
1-year progression-free survival (PFS) rate
Description
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.
Time Frame
1 year
Title
Duration of remission within 1 year (DOR)
Description
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.
Time Frame
1 year
Title
1-year overall survival (OS) rate
Description
The proportion of subjects who did not die from any cause after randomization for 1 year.
Time Frame
1 year
Title
1-year event-free survival (EFS) rate
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianfeng zhou, Doctor
Phone
13627284963
Email
jfzhoutj@163.com
Facility Information:
Facility Name
Shandong New Time Pharmaceutical Co., LTD
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohong Yin
Phone
86-15265901803
Email
yinshaohong@lunan.com.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
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