Clinical trial NCT05040906: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Recruiting
Keywords: DLBCL
CD20
R-CHOP
Lead sponsor: Shandong New Time Pharmaceutical Co., LTD
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Untreated CD20-positive DLBCL confirmed.
2. 18 years to 75 years; Male or female patients.
3. IPI score of 1 to 2 and an ECOG performance status of 0 to 2.
4. More than 6 months life expectancy.
5. At least one measurable lymph node:
6. 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.
7. Adequate cardiac function (LVEF≥50%).
8. 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.
9. Signed an informed consent form which was approved by the institutional review board of the respective medical center.

Exclusion Criteria

1. 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.
2. High-grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangement diagnosed by fluorescence in situ hybridization (FISH).
3. B-cell lymphoma has characteristics between DLBCL and classic HL, and cannot be divided into types.
4. 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.
5. 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.
6. Severe mental illness.
7. Positive for HIV infection.
8. Positive for HCV infection.
9. Patients who have HBV (+) are eligible.
10. History of anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
11. Previous treatment for NHL, including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy or surgical treatment (except lymph node biopsies diagnostic surgery and biopsy).
12. Participation in another clinical trial in the past 3 months.
13. Vaccination with a attenuated live vaccine within 4 weeks.
14. Use of hemopoietic cytokine in the past 2 weeks, e.g. granulocyte colony stimulating factor(G-CSF).
15. 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)
16. Known hypersensitivity to any of the study drugs or its ingredients.
17. Prior treatment with anthracycline.
18. DLBCL invaded by special parts such as testis, breast, ovary, etc.
19. Pregnant or lactating women.
20. The researcher believes that it is not suitable for enrollment.

Primary outcomes:
measure: ORR(based on the evaluation of the IRC)
timeFrame: 18 weeks
Secondary outcomes:
measure: ORR(based on the judgment of the investigator)
timeFrame: 18 weeks
measure: Complete response (CR) rate (based on the evaluation of the IRC and investigator)
timeFrame: 18 weeks
measure: 1-year progression-free survival (PFS) rate
timeFrame: 1 year
measure: Duration of remission within 1 year (DOR)
timeFrame: 1 year
measure: 1-year overall survival (OS) rate
timeFrame: 1 year
measure: 1-year event-free survival (EFS) rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Linyi
country: China
facility: Shandong New Time Pharmaceutical Co., LTD
state: Shandong
Study officials:
References: