Actively Recruiting
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
Led by Corvus Pharmaceuticals, Inc. · Updated on 2026-04-08
150
Participants Needed
34
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Histologically confirmed PTCL-NOS, FHTCLs, or sALCL
- Relapsed, refractory, progressed on, or intolerant to standard therapy with 1 to 3 prior systemic treatments
- Fluorodeoxyglucose-avid disease by PET and measurable disease at least 1.5 cm by CT
- Life expectancy greater than 12 weeks
- Adequate organ function including neutrophil count ≥ 1.0 x10^9/L, platelet count ≥ 100 x10^9/L, hemoglobin ≥ 9.0 g/dL, appropriate coagulation times, creatinine clearance ≥ 50 mL/min, bilirubin ≤ 1.5 x ULN (or per specified exceptions), liver enzymes ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases), serum albumin > 2.5 g/dL, and serum calcium < 12 mg/dL or corrected below ULN
- Recovery from previous treatment adverse events to Grade ≤ 1 or baseline except Grade ≤ 2 neuropathy, alopecia, and non-acute toxicities
- Females of childbearing potential must use highly effective contraception during and up to 120 days (soquelitinib) or 6 months (belinostat/pralatrexate) after treatment
- Non-sterilized males must use condom plus spermicide from Day 1 through 120 days after last dose
You will not qualify if you...
- Active central nervous system involvement of T-cell lymphoma
- Significant medical, laboratory, or psychiatric conditions preventing study participation
- History of primary immunodeficiency or solid organ transplantation
- Opportunistic infection within 30 days requiring active systemic treatment or active infection requiring IV therapy
- Active infection requiring IV therapy
- History of invasive malignancy requiring systemic therapy within last 3 years
- Any condition interfering with study data interpretation
- Known HIV positive or chronic hepatitis B or hepatitis C infection
- Recent monoclonal antibody therapy, radiotherapy, chemotherapy, or targeted therapy within specified time frames before study
- Prior treatment with an ITK inhibitor
- Need for immediate cytoreductive therapy
- Use of strong CYP3A inhibitors or inducers within 14 days prior to study
- History of allogeneic hematopoietic stem cell transplantation
- Candidate for stem cell transplantation at screening
- Progressive disease within 6 months of autologous stem cell transplantation
- Concurrent enrollment in another clinical study
- Females who are pregnant, breastfeeding, or planning pregnancy during and 6 months after study
- Inability to take medications orally or having malabsorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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