OncoMatch/Clinical Trials/NCT06561048
Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
Is NCT06561048 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Soquelitinib and Belinostat for peripheral t-cell lymphoma, not otherwise specified.
Treatment: Soquelitinib · Belinostat · Pralatrexate — A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed/refractory (R/R) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer
Cannot have received: ITK inhibitor
Prior administration of an ITK inhibitor
Cannot have received: monoclonal antibody therapy
Exception: within 3 weeks prior to first dose
Monoclonal antibody therapy for cancer ... within 3 weeks prior to the first dose of study treatment
Cannot have received: radiotherapy
Exception: within 3 weeks prior to first dose
radiotherapy ... within 3 weeks prior to the first dose of study treatment
Cannot have received: chemotherapy
Exception: within 3 weeks prior to first dose
chemotherapy ... within 3 weeks prior to the first dose of study treatment
Cannot have received: targeted therapy
Exception: within 2 weeks prior to first dose
targeted therapy within 2 weeks prior to the first dose of study treatment
Cannot have received: allogeneic hematopoietic stem cell transplantation
History of allogeneic hematopoietic stem cell transplantation
Cannot have received: autologous hematopoietic stem cell transplantation
Exception: progressive disease within 6 months
History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0×10^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor); Platelet count ≥ 100×10^9/L (without transfusion); Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug; Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × ULN, unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
Kidney function
Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute
Liver function
Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor; Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); Serum albumin > 2.5 g/dL
Adequate organ function as determined by: [see details]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center · Duarte, California
- University of California, Irvine · Irvine, California
- University of California San Francisco · San Francisco, California
- Yale University · New Haven, Connecticut
- Emory University · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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