OncoMatch/Clinical Trials/NCT04915248
Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.
Is NCT04915248 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Daratumumab and Bortezomib for plasmablastic lymphoma.
Treatment: Daratumumab · Bortezomib · Dexamethasone — It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD38 expression ≥5% (≥5% of positive cells by immunohistochemistry)
CD38-positive by immunohistochemistry (≥5% of positive cells)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: conventional-dose chemotherapy
relapsed or refractory after at least one line of conventional-dose chemotherapy
Cannot have received: anti-cancer therapy
Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy including targeted small molecule agents within 14 days prior to the first dose of study drug
Lab requirements
Blood counts
ANC <1.0 x 10^9/L (unless secondary to documented marrow involvement by lymphoma); Platelet count <75 x 10^9/L; Hemoglobin < 7.5 g/dL
Kidney function
Serum Creatinine Clearance < 20 ml/h
Liver function
ALT and/or AST > 3.5 x ULN; Alkaline phosphatase > 3.5 x ULN; Bilirubin > 2 x ULN (unless due to Gilbert's syndrome or non-hepatic origin)
Cardiac function
Myocardial infarction within 6 months; unstable or uncontrolled cardiac disease; Cardiac arrhythmia (CTCAE Grade 2 or higher) or clinically significant ECG abnormalities; QTcF > 470 msec
Screening laboratory values (due to causes different than lymphoma): ANC <1.0 x 10^9/L (unless secondary to documented marrow involvement by lymphoma); Platelet count <75 x 10^9/L; Hemoglobin < 7.5 g/dL; ALT and/or AST > 3.5 x ULN; Alkaline phosphatase > 3.5 x ULN; Bilirubin > 2 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); Serum Creatinine Clearance < 20 ml/h. Clinically significant cardiac disease, including: Myocardial infarction within 6 months before date of registration, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV); Cardiac arrhythmia (CTCAE current version Grade 2 or higher) or clinically significant ECG abnormalities. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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