Actively Recruiting
Study of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care in Adults With Relapsed/Refractory Peripheral T-cell Lymphoma, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma
Led by Corvus Pharmaceuticals, Inc. · Updated on 2026-04-08
150
Participants Needed
34
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of soquelitinib, an oral interleukin-2-inducible T cell kinase (ITK) inhibitor, compared to physician's choice standard of care treatment in adults with relapsed or refractory peripheral T-cell lymphoma not otherwise specified, follicular helper T-cell lymphomas, or systemic anaplastic large-cell lymphoma. This Phase 3, randomized, open-label study involves multiple centers and aims to understand which treatment may better manage these lymphomas. Participants will be randomly assigned to receive either soquelitinib tablets taken orally twice daily at 200 mg or a standard of care treatment chosen by their physician, which includes either belinostat given intravenously once daily for 5 days in each 21-day cycle or pralatrexate administered intravenously once weekly for 6 weeks in each 7-week cycle. The treatment period can last up to 2 years, or until unacceptable side effects or disease progression occurs. Participants receiving standard care who experience disease progression may switch to soquelitinib treatment. Throughout the study, participants will undergo various assessments including scans to measure disease, laboratory tests to monitor organ function, and evaluations of overall health and response to treatment. The main outcome measured is progression-free survival for up to 4 years after starting treatment, with additional measures including response rates and overall survival. Monitoring will continue throughout treatment and follow-up periods, supporting comprehensive safety and efficacy evaluation.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants 18 years of age or older at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Histologically confirmed diagnosis of peripheral T-cell lymphoma not otherwise specified, follicular helper T-cell lymphomas, or systemic anaplastic large-cell lymphoma
- Disease progressed on, refractory to, relapsed, or intolerant to standard therapy with 1 to 3 prior systemic treatments
- Fluorodeoxyglucose-avid disease confirmed by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography
- Life expectancy greater than 12 weeks
- Adequate organ function as defined by specific blood counts, liver function, kidney function, and coagulation parameters
- Recovery from all adverse effects of prior therapies to Grade 1 or baseline except for Grade 2 or lower neuropathy, alopecia, and non-acute toxicities
- Female participants of childbearing potential must use effective contraception during and after treatment as specified
- Non-sterilized males sexually active with female partners of childbearing potential must use condom plus spermicide during and after treatment as specified
You will not qualify if you...
- T-cell lymphoma with active central nervous system involvement
- Significant medical conditions, laboratory abnormalities, or psychiatric illness preventing study participation
- History of primary immunodeficiency or solid organ transplantation
- Recent opportunistic infection or active infection requiring intravenous therapy
- History of invasive malignancy requiring systemic therapy within past 3 years
- Conditions that interfere with data interpretation
- Positive test for HIV, chronic hepatitis B or C infection
- Recent monoclonal antibody therapy, radiotherapy, chemotherapy, or targeted therapy within specified time frames
- Prior use of ITK inhibitors
- Need for immediate cytoreductive therapy
- Use of strong CYP3A inhibitors or inducers shortly before study
- History of allogeneic hematopoietic stem cell transplantation or candidacy for stem cell transplantation
- Disease progression within 6 months of autologous stem cell transplantation
- Concurrent enrollment in another clinical study
- Females who are pregnant, lactating, or intend pregnancy during study and follow-up
- Inability to take oral medications or malabsorption issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until unacceptable toxicity or disease progression
Participants receive either soquelitinib orally twice daily or physician's choice standard of care treatment with belinostat or pralatrexate for their lymphoma.
Varies by treatment: soquelitinib taken orally twice daily; belinostat given by intravenous infusion once daily on Days 1-5 of each 21-day cycle; pralatrexate administered intravenously once weekly for 6 weeks in each 7-week cycle
Duration - Up to 4 years post study treatment initiation
Participants are monitored for disease progression and overall survival after treatment ends.
Visit schedule varies depending on participant status
Trial Site Locations
Total: 34 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC
Chicago, Illinois, United States, 60611
Actively Recruiting
8
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Roger Cancer Center University of Michigan Health
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
13
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
14
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
15
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
16
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
17
North Carolina Cancer Hospital
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
18
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
19
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
20
University of Washington Fred Hutch Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
21
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
22
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
23
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
24
ICON Cancer Centre
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
25
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
26
Flinders Medical Center
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
27
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
28
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
29
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
30
Epworth Healthcare
Richmond, Victoria, Australia, 3121
Actively Recruiting
31
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
32
BC Cancer Research Institute
Vancouver, British Columbia, Canada, V5Z4E6
Actively Recruiting
33
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
34
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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