Duvelisib + BMS-986345 for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen by Hayder Saeed, MD

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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug BMS-986345, in combination with duvelisib.

Research Team

Hayder Saeed, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

Adults with certain types of lymphoid malignancies, including various T-cell lymphomas and B-cell lymphomas, who have progressed after prior therapies. Participants must be over 18, have a performance status indicating they can carry out daily activities with little or no assistance, and not be pregnant or planning to conceive. They should also have adequate organ function.

Inclusion Criteria

I am 18 years old or older.

Willingness to avoid pregnancy or fathering children based on the following criteria

I have been diagnosed with a specific type of lymphoma or leukemia.

Exclusion Criteria

History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis

I cannot take preventive treatments for pneumocystis or herpes viruses.

I haven't had major heart problems or a heart attack in the last 6 months.

Treatment Details

Interventions

• CC-486 (DNA Methyltransferase Inhibitor)
• Duvelisib (PI3K Inhibitor)

Trial Overview The trial is testing the safety and optimal dose of BMS-986345 when used in combination with duvelisib for treating specific lymphoid cancers. It aims to determine how well patients tolerate this drug combo.

Participant Groups

Group I: Dose Escalation Experimental Treatment 2 Interventions

Dose escalation to determine the maximum tolerated dose (MTD) of BMS-986345 in combination with Duvelisib in patients with lymphoid malignancy. Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 6 dose levels will be used.

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

Secura Bio, Inc.

Industry Sponsor

Trials

9

Recruited

200+