A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-ce… (NCT03650933) | Clinical Trial Compass
UnknownPhase 3
A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients
China360 participantsStarted 2018-12-28
Plain-language summary
A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Previously untreated CD20 Positive DLBCL.
✓. International Prognostic Index (IPI) score of 0 to 2, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
✓. 18 years to 70 years; Male or female patients; Body Mass Index (BMI)≤2.13 m\^2.
✓. Expected survival more than 6 months.
✓. At least 1 bi-dimensionally measurable lesion: Nodal lesion: Greatest transverse diameter≥1.5cm and short axis≥1.0cm; Extra-nodal lesion: Greatest transverse diameter≥1.0cm.
✓. Cardiac echocardiography: LVEF≥50%.
✓. Adequate hematological function: WBC≥3 x 10\^9/L, HGB≥80g/L, ANC≥1.5 x 10\^9/L, PLT≥75 x 10\^9/L.
✓. Hepatic function: TBIL≤1.5 x ULN, ALT or AST≤2.5 x ULN, ALP≤3 x ULN if with no bone marrow infiltration, Renal function: Cr≤1.5 x ULN.
Exclusion criteria
✕. Other types of DLBCL: primary central nervous system DLBCL, primary skin DLBCL (leg type), EBV-positive DLBCL, NOS, EB virus-positive skin mucosal ulcer, chronic inflammation-related DLBCL, lymphomatoid granuloma, primary Mediastinal (thymus) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmablastic lymphoma, primary exudative lymphoma, HHV8+DLBCL, NOS, Burkitt's lymph Tumor, primary testicular lymphoma。
✕. Confirmed DLBCL with BCL-2 and c-MYC gene rearrangement or BCL-2, BCL-6, and c-MYC gene rearrangement by FISH. B-cell lymphomas, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma.
✕. Patients who have received therapy for non-Hodgkin's lymphoma: including chemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy);
✕. Patients who received continuous treatment of corticosteroid drugs lasting for more than 10 days. Prednisone with the dosage over 30mg/day; Other corticosteroid drugs with equal dosage.
✕. Patients who received cytotoxic drugs or anti-CD20 monoclonal antibody for other diseases (such as Rheumatoid arthritis).Or received any monoclonal antibody within 3 months prior to the enrollment of the study.
✕. Patients who participated in other clinical trials within 3 months prior to the enrollment of the study.