🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06561048
Recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Corvus Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-10-02
Last updated
2026-04-08

Condition(s) studied

Peripheral 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

Investigational drug(s) / intervention(s)

SoquelitinibBelinostatPralatrexate

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

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

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

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Adult participants ≥18 years of age on the day of signing the informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms. 4. 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. 5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist. 6. Life expectancy \>12 weeks. 7. Adequate organ function as determined by: * Absolute neutrophil count ≥ 1.0×10\^9/L (1000/mm3) (without receiving granulocyte-colony stimulating factor) * Platelet count ≥ 100×10\^9/L (without transfusion) * Hemoglobin ≥ 9.0 g/dL, without packed red blood cell transfusion within the last 1 week of starting study drug * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL/minute * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg/dL or discussion with the Medical Monitor * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases) * Serum albumin \> 2.5 g/dL * Serum calcium \< 12 mg/dL or corrected serum calcium \< ULN 8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following: * Grade ≤ 2 neuropathy * Alopecia and non-acute toxicities * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and/or complications from the intervention prior to starting study treatment 9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate. 10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug. Exclusion Criteria: 1. Participants who have T-cell lymphoma with active central nervous system involvement. 2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. 3. History of primary immunodeficiency or sold organ transplantation. 4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy. 5. Any active infection requiring IV therapy. 6. History of invasive prior malignancy that required systemic therapy within last 3 years. 7. Any condition that confounds the ability to interpret data from the study. 8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\]) or positive test for hepatitis C antibody. 9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment. 10. Prior administration of an ITK inhibitor. 11. Participants who need immediate cytoreductive therapy. 12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment. 13. History of allogeneic hematopoietic stem cell transplantation. 14. Candidate for hematopoietic stem cell transplantation at screening. 15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation. 16. Concurrent enrollment in another clinical study 17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment. 18. Participants who cannot ingest medications orally or who have malabsorption.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
University of California, Irvine Irvine California Recruiting
University of California San Francisco San Francisco California Recruiting
Yale University New Haven Connecticut Recruiting
Sylvester Comprehensive Cancer Center University of Miami Miller School of Medicine Miami Florida Recruiting
Emory University Atlanta Georgia Recruiting
North Western University Robert H. Lurie Comprehensive Cancer Center RHLCCC Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
University of Maryland Medical Center Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Roger Cancer Center University of Michigan Health Ann Arbor Michigan Recruiting
Washington University in St. Louis St Louis Missouri Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Cornell Medicine New York New York Recruiting
North Carolina Cancer Hospital Chapel Hill North Carolina Recruiting
The Ohio State University Columbus Ohio Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
University of Washington Fred Hutch Cancer Center Seattle Washington Recruiting
University of Wisconsin Carbone Cancer Center Madison Wisconsin Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Recruiting
St George Hospital Kogarah New South Wales Recruiting
ICON Cancer Centre South Brisbane Queensland Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Flinders Medical Center Bedford Park South Australia Recruiting
Royal Hobart Hospital Hobart Tasmania Recruiting
Box Hill Hospital Box Hill Victoria Recruiting
Austin Hospital Heidelberg Victoria Recruiting
Epworth Healthcare Richmond Victoria Recruiting
Linear Clinical Research Perth Western Australia Recruiting
BC Cancer Research Institute Vancouver British Columbia Recruiting
The Ottawa Hospital - General Campus Ottawa Ontario Recruiting
The Princess Margaret Cancer Centre Toronto Ontario Recruiting

More Corvus Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06561048 on ClinicalTrials.gov ↗ ← All trials in the USA