A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
NCT ID: NCT04014205
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
81 participants
INTERVENTIONAL
2019-11-18
2025-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 Dose Escalation
Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL
Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
Part 2 Dose Expansion
Arm 1: Patients with r/r MCL
Arm 2: Patients with other types of B-cell malignancies, including:
* CLL/SLL with/without prior treatment
* r/r FL
* r/r MZL
Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
Interventions
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Orelabrutinib (ICP-022)
ICP-022 The drug product is a white, round, uncoated tablet
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
4. Life expectancy (in the opinion of the investigator) of ≥ 4 months.
5. ECOG performance status of 0 \~1.
6. Must have adequate organ function.
7. Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection
Exclusion Criteria
2. Prior treatment with systemic immunotherapeutic agents.
3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
8. Active uncontrolled infections.
9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
10. Unresolved toxicities from prior anti-cancer therapy.
11. Medically apparent CNS lymphoma or leptomeningeal disease.
12. Current or previous history of CNS disease.
13. Major surgery or significant traumatic injury \< 28 days prior to the first dose of the study drug.
14. Patients with another invasive malignancy in the last 2 years.
15. Significant cardiovascular disease or active pulmonary disease.
16. Received systemic immunosuppressive medications.
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic-Mayo Clinic Hospital-Phoenix
Phoenix, Arizona, United States
Pacific Cancer Medical Center
Anaheim, California, United States
Los Angeles Cancer Network - Good Samaritan Hospital Location
Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States
The Oncology Institute of Hope & Innovation
Whittier, California, United States
Florida Cancer Specialists (FCS) South
Fort Myers, Florida, United States
Asclepes Research Centers - Weeki Wachee
Weeki Wachee, Florida, United States
Northwest Neurology - Rolling Meadows Office
Elk Grove Village, Illinois, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Goshen Center for Cancer Care
Goshen, Indiana, United States
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
Topeka, Kansas, United States
Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC
New Orleans, Louisiana, United States
Anne Arundel Medical Center (AAMC) Oncology and Hematology
Annapolis, Maryland, United States
Mayo Clinic - Minnesota
Rochester, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Summit Medical Group
Florham Park, New Jersey, United States
Clinical Research Alliance
Westbury, New York, United States
Gabrail Cancer Research Center
Canton, Ohio, United States
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Guthrie Cancer Center
Sayre, Pennsylvania, United States
Prairie Lakes Cancer Center
Watertown, South Dakota, United States
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical Oncology Associates PS (dba Summit Cancer Centers)
Spokane, Washington, United States
Soroka Medical Center
Beersheba, , Israel
Carmel Medical Center
Haifa, , Israel
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Cherkassy Regional Oncology Center
Cherkasy, , Ukraine
Khmelnytskyi Regional Hospital
Khmelnytskyi, , Ukraine
St. Luke's Hospital - Medical and Diagnostic Center
Kropyvnytskyi, , Ukraine
National Cancer Institute
Kyiv, , Ukraine
Institute of Blood Pathology and Transfusion Medicine
Lviv, , Ukraine
Transcarpathian Regional Clinical Hospital named after Andrii Novak
Uzhhorod, , Ukraine
Countries
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Other Identifiers
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ICP-CL-00107
Identifier Type: -
Identifier Source: org_study_id
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