NCT02309580

Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

A Multicenter Phase I Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 clinical trial, a type of research study. The purpose of this phase 1 clinical trial is to find out whether a new study drug, ibrutinib, is safe in patients with T-cell non-Hodgkin lymphoma that has either come back or not responded to treatment. In this phase 1 study, different doses of ibrutinib (560 mg and 840 mg daily) will be tested to see what effect the drug has on the patient and the disease.

Conditions

• T-cell Lymphoma
• Relapsed and Refractory T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib will be administered once daily continuously until disease progression (confirmed by two assessments for CTCL patients only) or intolerance. The dose levels for the Phase 1 portion of the study. Either 560 mg (4 X 140 mg capsules) or 840 mg (6 X 140 mg capsules) doses will be administered. After the recommended expansion dose is established, an expansion cohort of 12 additional patients will be treated at the recommended expansion dose to further characterize the safety at that dose and to further assess preliminary efficacy

Timeline

• Start date: 2015-01-01
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2014-12-05
• Last updated: 2023-05-09

Locations

2 sites across 1 country: United States