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OncoMatch/Clinical Trials/NCT06390956

Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL)

Is NCT06390956 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Rituximab for marginal zone lymphoma.

Phase 2RecruitingUniversity of UtahNCT06390956Data as of Jun 2026

Treatment: Pirtobrutinib · RituximabThe purpose of this clinical trial is to learn if the drugs Pirtobrutinib and Rituximab are effective for the treatment of newly diagnosed marginal zone lymphoma.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Rituximab

Targeted therapy

Pirtobrutinib

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Must have received: antibiotic therapy — for H. pylori, C. psittaci, and B. burgdorferi

Prior antibiotic therapy for H. pylori, C. psittaci, and B. burgdorferi

Must have received: antiviral therapy — for HCV

Prior antiviral therapy for HCV

Lab requirements

Blood counts

ANC ≥ 750 cells/mm3 (≥ 0.75 x 10^9/L) independent of G-CSF support (≥500 if bone marrow involvement or splenomegaly); Platelet count ≥ 50,000/mm3 (≥30,000 if bone marrow involvement); Hemoglobin ≥ 8 g/dL (≥7 g/dL if bone marrow involvement or splenomegaly)

Kidney function

Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula

Liver function

Total Bilirubin ≤ 1.5x ULN (≤3x ULN if liver involvement); AST(SGOT)/ALT(SGPT) ≤ 3 × ULN (≤5x ULN if liver metastases)

Cardiac function

QTcF ≤ 470 ms; LVEF ≥ 40% within 12 months prior to first dose

Adequate organ function as defined as: Hematologic: ANC ≥ 750 cells/mm3...; Platelet count ≥ 50,000/mm3...; Hemoglobin ≥ 8 g/dL...; Hepatic: Total Bilirubin ≤ 1.5x ULN...; AST(SGOT)/ALT(SGPT) ≤ 3 × ULN...; Renal: Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula; aPPT or PT or INR ≤ 1.5 X ULN; Cardiac: QTcF > 470 ms excluded, LVEF < 40% excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Washington University · St Louis, Missouri
  • Huntsman Cancer Institute at University of Utah · Salt Lake City, Utah

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06390956 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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