Study on Orelabrutinib for Patients with Relapsed or Refractory B-Cell Blood Cancers
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor score: 0
ClinicalTrials ID:NCT04014205
This clinical trial is testing a new drug called Orelabrutinib to see if it is safe and effective for treating patients with certain types of B-cell blood cancers that have returned or not responded to previous treatments.
Patient Parameters
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Program Overview
This study is exploring the safety and effectiveness of a new medication, Orelabrutinib, for patients with B-cell blood cancers that have either come back or not responded to treatment. The study is divided into two parts: the first part will determine the best dose of the drug, and the second part will further test its effectiveness at that dose.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of certain types of B-cell blood cancers, such as follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma.
- Have a life expectancy of at least 4 months.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function.
- Test negative for active hepatitis B or C infections.
Exclusion Criteria
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have previously received certain immune therapies.
- Have known allergies to the study drug or its ingredients.
- Have HIV infection.
- Have received chemotherapy or other investigational treatments within 4 weeks before starting the study drug.
- Have had a stem cell or organ transplant.
- Have received radiation therapy within 6 weeks before starting the study drug.
- Are taking certain blood thinners or medications that affect the liver.
- Have active, uncontrolled infections.
- Have had a recent serious infection requiring IV treatment within 14 days before starting the study drug.
- Have unresolved side effects from previous cancer treatments.
- Have cancer that has spread to the brain or spinal cord.
- Have had major surgery or a significant injury within 28 days before starting the study drug.
- Have another invasive cancer diagnosed in the last 2 years.
- Have significant heart or lung disease.
- Are taking medications that suppress the immune system.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic-Mayo Clinic Hospital-Phoenix | 85054-4502 | Phoenix | Arizona |
| Pacific Cancer Medical Center | 92801-1824 | Anaheim | California |
| Los Angeles Cancer Network - Good Samaritan Hospital Location | 90017 | Los Angeles | California |
| Desert Hematology Oncology Medical Group, Inc. | 92270 | Rancho Mirage | California |
| The Oncology Institute of Hope & Innovation | 90603 | Whittier | California |
| Florida Cancer Specialists (FCS) South | 33901 | Fort Myers | Florida |
| Asclepes Research Centers - Weeki Wachee | 34607 | Weeki Wachee | Florida |
| Northwest Neurology - Rolling Meadows Office | 60007 | Elk Grove Village | Illinois |
| Orchard Healthcare Research Inc. | 60077 | Skokie | Illinois |
| Goshen Center for Cancer Care | 46526 | Goshen | Indiana |
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