Siltuximab for Leukemia

Overseen by Ning Dong, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing siltuximab, a drug that blocks a protein to help treat a rare blood cancer called LGLL. The goal is to see if it is safe and effective for these patients. Siltuximab has shown promise in treating multiple myeloma, B-cell non-Hodgkin lymphoma, and Castleman disease, leading to its approval for Castleman disease by the FDA.

Research Team

Ning Dong, MD, MS

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

Adults diagnosed with large granular lymphocytic leukemia (LGLL) who are willing to follow study procedures. Eligible participants can be new or previously treated for LGLL, must have certain blood cell counts or symptoms like severe neutropenia, recurrent infections, anemia, or thrombocytopenia. They should not have other active cancers (with some exceptions), coexisting conditions that could affect the trial's outcome, and must agree to contraception use.

Inclusion Criteria

For females of reproductive potential: use of highly effective contraception as specified

Provision of signed and dated informed consent form

Creatinine clearance (CLCr) ≥15 mL/min

Exclusion Criteria

Known severe allergic reactions to siltuximab

Pregnancy or lactation

I do not have any infections needing treatment through my bloodstream.

Treatment Details

Interventions

• Siltuximab (Monoclonal Antibodies)

Trial Overview The trial is testing the safety and effectiveness of siltuximab in treating LGLL. Participants will receive this medication and their response will be monitored to determine if it helps manage their condition better than existing treatments.

Participant Groups

Group I: Siltuximab Experimental Treatment 1 Intervention

Siltuximab will be given every 3 weeks, for between 18 and 36 weeks

Siltuximab is already approved in Canada, Japan for the following indications:

Approved in Canada as Sylvant for:

• Multicentric Castleman's disease

Approved in Japan as Sylvant for:

• Multicentric Castleman's disease

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Patrick Hwu

H. Lee Moffitt Cancer Center and Research Institute

Chief Executive Officer since 2020

MD from The Medical College of Pennsylvania

Wade J. Sexton

H. Lee Moffitt Cancer Center and Research Institute

Chief Medical Officer

MD

EUSA Pharma, Inc.

Industry Sponsor

Trials

6

Recruited

1,300+