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Study of Ibrutinib in Relapsed and Refractory T-cell Lymphoma

NCT02309580 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-05-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Anita Kumar, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2023-05-08
Completion
2023-05-08

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309580 on ClinicalTrials.gov