OncoMatch/Clinical Trials/NCT04855695
Avo In R/R And Previously Untreated MCL
Is NCT04855695 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell 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 →Frequently asked questions
Is NCT04855695 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BTK inhibitor, BCL2 inhibitor disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 high expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify