OncoMatch/Clinical Trials/NCT06675123
Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma
Is NCT06675123 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BTK Inhibitor and Pacritinib for recurrent mantle cell lymphoma.
Treatment: BTK Inhibitor · Pacritinib — This phase I trial tests the safety and side effects of pacritinib in combination with a Bruton's tyrosine kinase (BTK) inhibitor and how well it works in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. BTK inhibitors block a protein called BTK which is present on B-cell (a type of white blood cell) cancers such as mantle cell lymphoma at abnormal levels. This may help keep tumor cells from growing and spreading. Giving pacritinib in combination with a BTK inhibitor may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: CCND1 overexpression
cyclin D1 expression by immunohistochemistry (IHC)
Allowed: CCND1 t(11;14) translocation
positive by fluorescence in situ hybridization (FISH) or cytogenetics for the t(11,14) translocation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib) — single agent
Patient must be receiving treatment with single agent ibrutinib or another covalent BTK inhibitor (e.g., acalabrutinib, zanubrutinib), and must have previously achieved complete response (CR) or partial response (PR) to the BTK inhibitor, and must show evidence of progressive MCL at the time of enrollment
Cannot have received: autologous hematopoietic stem cell transplant
Exception: within 3 months of day 1 of protocol therapy
Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant
Cannot have received: JAK2 inhibitor
Prior treatment with pacritinib or a janus kinase 2 (JAK2) inhibitor
Cannot have received: BTK inhibitor (pirtobrutinib)
Exception: concomitant treatment
Concomitant treatment with pirtobrutinib
Lab requirements
Blood counts
WITHOUT BONE MARROW INVOLVEMENT: ANC ≥ 1,000/mm^3, Platelets ≥ 75,000/mm^3; WITH BONE MARROW INVOLVEMENT: ANC ≥ 500/mm^3, Platelets ≥ 25,000/mm^3
Kidney function
Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 4 x ULN (≤ 3 x ULN if hepatic involvement by lymphoma or Gilbert's disease); AST ≤ 3 x ULN (≤ 5 x ULN if hepatic involvement by lymphoma); ALT ≤ 3 x ULN (≤ 5 x ULN if hepatic involvement by lymphoma)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%; Mean corrected QT interval (QTc) ≤ 480 ms
Total bilirubin ≤ 4 x ULN (If hepatic involvement by lymphoma, or Gilbert's disease: ≤ 3 x ULN); AST ≤ 3 x ULN (If hepatic involvement by lymphoma: AST ≤ 5 x ULN); ALT ≤ 3 x ULN (If hepatic involvement by lymphoma: ALT ≤ 5 x ULN); Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula; WITHOUT BONE MARROW INVOLVEMENT: ANC ≥ 1,000/mm^3, Platelets ≥ 75,000/mm^3; WITH BONE MARROW INVOLVEMENT: ANC ≥ 500/mm^3, Platelets ≥ 25,000/mm^3; Left ventricular ejection fraction (LVEF) ≥ 50%; Mean corrected QT interval (QTc) ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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