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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

ConditionsPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell LymphomaFollicular T-Cell LymphomaNodal Peripheral T-Cell Lymphoma With TFH PhenotypeSystemic Anaplastic Large Cell LymphomaLymphoma, T-Cell, PeripheralLymphoma, T-Cell
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorvus Pharmaceuticals, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult participants ≥18 years of age on the day of signing the informed consent form.

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.

Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.

Disqualifiers

Participants who have T-cell lymphoma with active central nervous system involvement.

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.

History of primary immunodeficiency or sold organ transplantation.

History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Soquelitinib

    Drug

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

  • Belinostat

    Drug

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

  • Pralatrexate

    Drug

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: SoquelitinibExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival

Time from first study treatment to first occurrence of progression (as assessed by the Independent Review Committee) or death, whichever occurs first

Time frame
Up to 4 years post study treatment initiation

Secondary outcomes

1

Objective response rate

The rate of participants who achieve a partial response or complete response as assessed by the Independent Review Committee according to the Revised Criteria for Response Assessment of Malignant Lymphoma (Lugano Classification 2014), and modified Severity Weighted Assessment Tool (mSWAT) for participants with skin involvement

Time frame
Up to 2 years post study treatment initiation
2

Overall survival

Time from first study treatment to death from any cause

Time frame
Up to 4 years post study treatment initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corvus Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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