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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

NCT06561048 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-08

No results posted yet for this study

Summary

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).

Conditions

  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Angioimmunoblastic T-cell Lymphoma
  • Follicular T-Cell Lymphoma
  • Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
  • Systemic Anaplastic Large Cell Lymphoma
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, T-Cell

Interventions

DRUG

Soquelitinib

Soquelitinib 200 mg tablets will be taken by mouth two times a day

DRUG

Belinostat

Belinostat (1000 mg/m2) will be administered by intravenous infusion once daily on Days 1 through 5 of each 21-day cycle

DRUG

Pralatrexate

Pralatrexate (30 mg/m2) will be administered intravenously over 3 to 5 minutes once weekly for 6 weeks in each 7-week cycle

Sponsors & Collaborators

  • Corvus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Suresh Mahabhashyam, MD, MPH · Corvus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2027-11-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06561048 on ClinicalTrials.gov