MedTrace Logo

Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.

NCT02611908 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-01-25

No results posted yet for this study

Summary

The purpose of the study is to investigate whether the combination of obinutuzumab and ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL that is not responding or no longer responding to treatment with ibrutinib alone. The study will evaluate whether this regimen can reduce the amount of cancerous cells in the body. Subjects will be treated with ibrutinib at a dose of up to 840 mg a day by mouth, as well as obinutuzumab infusions. Although both of these agents are approved by the FDA for the treatment of CLL or SLL, the combination and the dosing schedule of ibrutinib are considered experimental.

Conditions

Interventions

DRUG

ibrutinib

Cohort 1 420 mg PO daily Cohort 2 560 mg PO daily Cohort 3 700 mg PO daily Cohort 4 840 mg PO daily

DRUG

obinutuzumab

obinutuzumab 100 mg IV on day 1, 900mg IV on day 2, 1000mg IV day 8, 15, 28 then q 28 days for a total of 8 doses.

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Michael Choi

    lead OTHER

Principal Investigators

  • Michael Choi, MD · University of California, San Diego

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-11-30
Completion
2020-11-30
FDA Drug
Yes

More Related Trials

Entities

Drugs
Diseases

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 NCT02611908 on ClinicalTrials.gov