A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Di… (NCT05040906) | Clinical Trial Compass
UnknownPhase 3
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
China416 participantsStarted 2020-10-13
Plain-language summary
This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase â…¢ 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
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.