NCT03939182

Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

Phase I Study of Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of abexinostat at different doses to find out if it can work with ibrutinib to stop the cancer from growing.

Conditions

• Diffuse Large B-cell Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Abexinostat	Two doses of the abexinostat will be tested: 30 mg/m2 and 45 mg/m2 orally twice daily, 7 days/week given every other week during a 28-day cycle.
DRUG	Ibrutinib	Ibrutinib will be given at the FDA-approved dose for mantle cell lymphoma (MCL) of 560 mg orally daily for 28 day cycle.

Timeline

• Start date: 2019-05-29
• Primary completion: 2025-04-22
• Completion: 2025-04-22
• First posted: 2019-05-06
• Last updated: 2025-04-25

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study