OncoMatch/Clinical Trials/NCT04855695
Avo In R/R And Previously Untreated MCL
Is NCT04855695 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Acalabrutinib and Venetoclax for mantle cell lymphoma.
Treatment: Acalabrutinib · Venetoclax · Obinutuzumab — This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab - as a possible treatment for relapsed or refractory and untreated mantle cell lymphoma (MCL). The names of the study drugs involved in this study are: * Acalabrutinib * Venetoclax * Obinutuzumab
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: TP53 mutation (variant allele fraction above validated threshold)
TP53 mutation detected by next generation sequencing at a variant (mutant) allele fraction above the validated threshold for calling a new variant
Required: TP53 wild-type
no evidence of TP53 mutation (TP53 wild type) detected by next generation sequencing
Required: TP53 high expression (>50% positive lymphoma cells)
high TP53 expression on immunohistochemistry (>50% positive lymphoma cells)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
Relapsed or primary refractory after at least one line of therapy including anti-CD20 monoclonal antibody treatment (part A)
Cannot have received: BTK inhibitor
Participants who have progressed or relapsed after receiving either a BTK inhibitor or BCL2 inhibitor.
Cannot have received: BCL2 inhibitor
Participants who have progressed or relapsed after receiving either a BTK inhibitor or BCL2 inhibitor.
Lab requirements
Blood counts
ANC ≥ 750/mm3 (0.75 x10^9/L) unless due to marrow involvement, then ≥ 500/mm3 (0.5x10^9/L); Platelets ≥ 75,000/mm3 (75 x10^9/L) unless due to marrow involvement, then ≥ 50,000/mm3 (50 x10^9/L); Hemoglobin ≥ 8.0 g/dL unless due to marrow involvement, then ≥ 7.0 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 50 ml/min (24-hour urine or calculated) or GFR ≥ 50 ml/min/1.73 m2 (CKD-EPI equation)
Liver function
Total bilirubin ≤ 2x ULN (unless liver involvement, hemolysis, or Gilbert's disease, then direct bilirubin ≤ 3x ULN); AST and ALT ≤ 2.5x ULN (≤ 5x ULN if liver involvement)
Participants must have adequate organ and marrow function as defined below: ... (see details above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Chicago Medical Center · Chicago, Illinois
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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