Soquelitinib for Peripheral T-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Corvus Pharmaceuticals, Inc.

Must not be taking: Monoclonal antibodies, Chemotherapy

Disqualifiers: Active CNS lymphoma, HIV, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have had monoclonal antibody therapy, radiotherapy, or chemotherapy within 3 weeks, and targeted therapy within 2 weeks before starting the study treatment.

Eligibility Criteria

This trial is for adults over 18 with certain types of T-cell lymphoma who have tried up to three treatments that didn't work or they couldn't tolerate. They should be relatively active (able to care for themselves), have a life expectancy over 12 weeks, and their cancer must show on scans.

Inclusion Criteria

My cancer did not respond or stopped responding to 1-3 standard treatments.

I am 18 years or older.

My cancer shows up on PET scans and has a tumor at least 1.5 cm big on CT scans.

+4 more

Exclusion Criteria

I had cancer that needed treatment throughout my body in the last 3 years.

Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study

My T-cell lymphoma affects my brain or spinal cord.

+8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either soquelitinib or physician's choice standard of care treatment for up to 2 years

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Crossover

Participants on standard of care with disease progression may crossover to receive soquelitinib

Participant Groups

The study compares Soquelitinib, a new treatment, against the standard drugs chosen by the doctor (Belinostat or Pralatrexate) in patients with specific T-cell lymphomas. It's an open-label Phase 3 trial where participants are randomly assigned to one of two groups.

2Treatment groups

Experimental Treatment

Active Control

Group I: SoquelitinibExperimental Treatment1 Intervention

Participants will administer soquelitinib 200 mg orally twice daily for up to 2 years

Group II: Standard of CareActive Control2 Interventions

Participants will receive physician's choice standard of care treatment of either pralatrexate or belinostat for up to 2 years