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

Part of paid clinical trials in Duarte, California.

Sponsor
Corvus Pharmaceuticals, Inc.
Study ID
NCT06561048
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Oct 2, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Soquelitinib
    Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years
  • Active Comparator: Standard of Care
    Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years

Primary Outcome Measure

Progression-free survival [ Time Frame: Up to 4 years post study treatment initiation ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Christina Poh, MD
[email protected]
626-713-7102
Christina Poh, MD (PRINCIPAL_INVESTIGATOR)
University of California, IrvineIrvineCalifornia92697
Research Contact
[email protected]
University of California San FranciscoSan FranciscoCalifornia94143
Weiyun Ai, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06520
Daniel Moncayo
[email protected]
203-500-0834
Francine Foss, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer Center University of Miami Miller School of MedicineMiamiFlorida33136
305-242-5302
Emory UniversityAtlantaGeorgia30322
Blair Dykeman
[email protected]
404-778-8641
North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCCChicagoIllinois60611
Jonathan Moreira, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Dr. Eric Mou, MD
[email protected]
319-356-1616
Eric Mou, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical CenterBaltimoreMaryland21201
Hongxia Li
[email protected]
410-328-7996
Kathryn Kline, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Dr. Salvia Jain, MD
[email protected]
617-724-4000
Salvia Jain, MD (PRINCIPAL_INVESTIGATOR)
Roger Cancer Center University of Michigan HealthAnn ArborMichigan48109
Cancer Answer Line
[email protected]
1-800-865-1125
Ryan Wilcox, MD (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63130
Anne Fischer
[email protected]
314-581-0588
Neha Mehta-Shah, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Elizabeth McCarthy
[email protected]
(412) 860-6447
Tatyana Feldman, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Patricia Worker
[email protected]
(212) 824-7337 (x57337)
Roshan Asrani, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Dr. Jasmine Zain
[email protected]
Jasmine Zain, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Tejasvi Sahni
[email protected]
Jia Ruan, MD, PHD (PRINCIPAL_INVESTIGATOR)
North Carolina Cancer HospitalChapel HillNorth Carolina27514
Cancer Clinical Trials Office
[email protected]
Anne Beaven, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Madeline Gaines
[email protected]
614-688-8894
John Reneau, MD, PHD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Dr. Swaminathan Iyer, MD
[email protected]
1-877-632-6789
Swaminathan Iyer, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Fred Hutch Cancer CenterSeattleWashington98109
Research Contact
[email protected]
Stephen Smith, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922

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