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Active, not recruiting Phase 1Phase 2 Interventional

A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

ClinicalTrials.gov ID: NCT04014205

Public ClinicalTrials.gov record NCT04014205. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 8:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II,Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).

Study identification

NCT ID
NCT04014205
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
81 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 18, 2019 (Actual)
Primary completion
Jun 30, 2026 (Estimated)
Completion
Jun 30, 2026 (Estimated)
Last update posted
Jun 8, 2026

2019 – 2026

United States locations

U.S. sites
27
U.S. states
18
U.S. cities
27
Facility City State ZIP Site status
Mayo Clinic-Mayo Clinic Hospital-Phoenix Phoenix Arizona 85054-4502 —
Pacific Cancer Medical Center Anaheim California 92801-1824 —
Los Angeles Cancer Network - Good Samaritan Hospital Location Los Angeles California 90017 —
Desert Hematology Oncology Medical Group, Inc. Rancho Mirage California 92270 —
The Oncology Institute of Hope & Innovation Whittier California 90603 —
Florida Cancer Specialists (FCS) South Fort Myers Florida 33901 —
Asclepes Research Centers - Weeki Wachee Weeki Wachee Florida 34607 —
Northwest Neurology - Rolling Meadows Office Elk Grove Village Illinois 60007 —
Orchard Healthcare Research Inc. Skokie Illinois 60077 —
Goshen Center for Cancer Care Goshen Indiana 46526 —
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center) Topeka Kansas 66606 —
Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC New Orleans Louisiana 70112 —
Anne Arundel Medical Center (AAMC) Oncology and Hematology Annapolis Maryland 21401-3093 —
Mayo Clinic - Minnesota Rochester Minnesota 55905-0001 —
Coborn Cancer Center Saint Cloud Minnesota 56303 —
Southeast Nebraska Cancer Center Lincoln Nebraska 68510-2496 —
Summit Medical Group Florham Park New Jersey 07932-0001 —
Clinical Research Alliance Westbury New York 11590 —
Gabrail Cancer Research Center Canton Ohio 44718 —
University of Pittsburgh - Hillman Cancer Center Pittsburgh Pennsylvania 15232 —
Guthrie Cancer Center Sayre Pennsylvania 18840 —
Prairie Lakes Cancer Center Watertown South Dakota 57201 —
Tennessee Oncology - Chattanooga Oncology & Hematology Associates Chattanooga Tennessee 37404-1130 —
Tennessee Cancer Specialists Knoxville Tennessee 37909-1327 —
Sarah Cannon Research Institute - Tennessee Oncology Nashville Tennessee 37203-1625 —
MD Anderson Cancer Center Houston Texas 77030 —
Medical Oncology Associates PS (dba Summit Cancer Centers) Spokane Washington 99201 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04014205, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 8, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04014205 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →