A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physicians Choice Standard of Care Treatment (Selected Single Agent) in Participants with Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Date Added
September 14th, 2026
PRO Number
Pro00150126
Researcher
Ashwath Gurumurthi

List of Studies

Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for patients diagnosed with relapsed or refractory T-cell lymphomas. These include:

Peripheral T‑cell lymphoma, not otherwise specified (PTCL-NOS)

Follicular helper T‑cell lymphoma (TFH lymphoma)

Systemic anaplastic large‑cell lymphoma (sALCL)

The study is testing a drug called Soquelitinib. This drug is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA).
The purpose of the study is to see how well soquelitinib works compared with standard treatment chosen by a physician. Standard treatment may include:

Belinostat (BELEODAQ®)

Pralatrexate (FOLOTYN®)

The study may last up to 6 years. Study treatment may last up to 2 years (104 weeks). Study visits will happen based on the treatment schedule for the assigned study drug.About 180 people will be screened for the study. About 150 participants will be randomly assigned to a treatment group.Soquelitinib works by blocking an enzyme called ITK. ITK is part of a signaling pathway that helps certain cancer cells grow. Blocking ITK may slow or stop the growth of cancer T cells.
Soquelitinib has not been approved for use in humans and is considered experimental. It is not known if the drug will work for this cancer. The possible side effects are also not fully known. About 70 patients have received soquelitinib in another clinical trial. In those patients, the drug was generally tolerated.In this study, treatment with soquelitinib will be compared with standard treatments used for this type of cancer.Belinostat is approved in the United States for adults with relapsed or refractory PTCL.Pralatrexate is approved in several countries, including the United States, Canada, Australia, and South Korea, for patients with relapsed or refractory PTCL.
Participants will be placed into treatment groups by randomization. Randomization means assignment to a group by chance, similar to flipping a coin. Each participant has an equal chance of receiving any of the study treatments.

Institution
MUSC
Recruitment Contact
Hannah Mendiola
843-792-9321
hcc-clinicaltrials@musc.edu

Radiotherapy with Concurrent Cetuximab vs. Carboplatin and Paclitaxel in Patients with Locoregionally Advanced Head and Neck Cancer with aContraindication to Cisplatin: A Pragmatic Phase III Randomized Trial (CONCISE)

Date Added
September 16th, 2026
PRO Number
Pro00152348
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for people with advanced head and neck cancer who cannot receive cisplatin. The purpose of this study is to compare treating head and neck cancer with radiation plus cetuximab versus radiation plus chemotherapy (carboplain and paclitaxel). Carboplatin, paclitaxel, and cetuximab are approved by the FDA to treat head and neck cancer.

If you agree to take part, we expect that your participation in this study may last up to 3 years. This includes visits to the clinic after you finish all study treatments. These follow-up visits will take place about every 2 months during the 1st year and about every 4 months thereafter.

Risks may include nausea, vomiting, headache, feeling tired, loss of appetite, and hair loss. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu



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