A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

NCT ID: NCT05040906

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2023-12-31

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.

Conditions

Recruiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

H02+ Chemotherapy

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).

Group Type: EXPERIMENTAL

H02+CHOP

Intervention Type: DRUG

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+Chemotherapy

Participants received six cycles of Rituxan combined with six cycles of standard cyclophosphamide,doxorubicin,vincristine,and prednisone(CHOP) chemotherapy(21-day cycles).

Group Type: ACTIVE_COMPARATOR

Rituxan +CHOP

Intervention Type: DRUG

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.

Interventions

H02+CHOP

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

Rituxan +CHOP

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong New Time Pharmaceutical Co., LTD

Linyi, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

jianfeng zhou, Doctor

Role: CONTACT

jfzhoutj@163.com

13627284963

Facility Contacts

Shaohong Yin

Role: primary

yinshaohong@lunan.com.cn

86-15265901803

Other Identifiers

NTP-H02-Ⅰ-Ⅲ

Identifier Type: -

Identifier Source: org_study_id