OncoMatch/Clinical Trials/NCT04161248
Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
Is NCT04161248 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for lymphoma, b-cell.
Treatment: Venetoclax · Rituximab · Rituximab SC · Gemcitabine · Dexamethasone · Cisplatin · Glofitamab · Tafasitamab — The purpose of this study is to find the highest dose of a new drug, in combination with standard drugs, which can be tolerated without causing very severe side effects. The study treatment is new agents in combination with R-GDP or an equivalent regimen.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: cytotoxic chemotherapy (R-CHOP, R-CEOP, dose-adjusted EPOCH-R, CODOX-M/IVAC-R) — first-line
Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have biopsy-proven refractory disease, after one prior line of therapy (R-CHOP chemotherapy or equivalent). R-CHOP chemotherapy equivalents include R-CEOP, dose-adjusted EPOCH-R, CODOX-M/IVAC-R, and other combination regimens including a CD20 monoclonal antibody, alkylating agent and anthracycline.
Lab requirements
Blood counts
Absolute Neutrophil ≥ 1.0 x 10^9/L (independent of growth factor support); Platelets ≥ 100 x 10^9/L (50 x 10^9/L if bone marrow involvement by lymphoma, independent of transfusion support)
Kidney function
Serum Creatinine ≤ 1.5x ULN (or estimated GFR of ≥ 45 mL/min/1.73 m2 using Cockcroft Gault formula)
Liver function
AST and ALT ≤ 3x ULN; Serum total bilirubin ≤ 1.5x ULN (≤ 5x ULN if Gilberts Disease)
Cardiac function
Patients with known left ventricular ejection fraction (LVEF) < 40% excluded; Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure excluded
Laboratory Requirements: (must be done within 14 days of enrollment) * Absolute Neutrophil ≥ 1.0 x 10^9/L (independent of growth factor support) * Platelets ≥ 100 x 10^9/L (50 x 10^9/L if bone marrow involvement by lymphoma, independent of transfusion support) * AST and ALT ≤ 3x ULN * Serum total bilirubin≤ 1.5x ULN (≤ 5x ULN if Gilberts Disease) * Serum Creatinine ≤ 1.5x ULN (or estimated GFR of ≥ 45 mL/min/1.73 m2 using Cockcroft Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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