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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    416
  • sponsor
    Shandong New Time Pharmaceutical Co., LTD
Updated on 16 September 2021

Summary

This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase 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.

Details
Condition Recruiting
Treatment H02+CHOP, Rituxan +CHOP
Clinical Study IdentifierNCT05040906
SponsorShandong New Time Pharmaceutical Co., LTD
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

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 (LVEF50%)
Absolute neutrophil count(ANC) 1.5 _109/L and platelet count(PLT) 75_ 109/L and hemoglobin 75g/L, total bilirubin level 1.5upper limit of normal (ULN), aspartic acid Aminotransferase (AST), alanine aminotransferase (ALT)2.5ULN, creatinine level (Cr)1.5ULN
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 (SBP180mmHg and/or DBP100mmHg), 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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