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

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Date Added
July 8th, 2026
PRO Number
Pro00151372
Researcher
Ashwath Gurumurthi

List of Studies

Keywords
Cancer
Summary

This study is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose disease has returned after treatment or has not responded to treatment, and who have previously received a Bruton tyrosine kinase (BTK) inhibitor.

This study is testing an investigational drug called BGB-16673. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).

This is a randomized study, which means participants are assigned by chance (like flipping a coin) to receive either BGB-16673 or pirtobrutinib.The primary purpose of this study is to compare the safety and effectiveness of BGB-16673 with pirtobrutinib in patients with relapsed or refractory CLL or SLL.The study drugs are taken by mouth. Participants will attend regular study visits for health assessments, laboratory tests, and disease evaluations and will remain in the study until their disease worsens, they experience unacceptable side effects, choose to leave the study, or the study ends.

Institution
MUSC
Recruitment Contact
Emma Bryan
843-792-9321
bryane@musc.edu

A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients with Peripheral T-Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)

Date Added
March 10th, 2026
PRO Number
Pro00149742
Researcher
Ashwath Gurumurthi

List of Studies

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

This phase III trial compares the effectiveness of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Participants will be separated into two groups, or randomized (like flipping a coin). The first group of participants will receive high dose chemotherapy followed by an autologous stem cell transplant. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. The second group will be observed by the study doctor and study team with check-ins every six months for 12 years after joining the trial. The group of participants who receive a stem cell transplant will also be checked by their doctor and study team for every 6 months for 12 years after joining the study. The main risks of the study treatment include reduced blood cell counts, nausea and vomiting, and damage to other organs (due to high dose chemotherapy).

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



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