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

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

FACILITYZIPCITYSTATE
Mayo Clinic-Mayo Clinic Hospital-Phoenix85054-4502PhoenixArizona
Pacific Cancer Medical Center92801-1824AnaheimCalifornia
Los Angeles Cancer Network - Good Samaritan Hospital Location90017Los AngelesCalifornia
Desert Hematology Oncology Medical Group, Inc.92270Rancho MirageCalifornia
The Oncology Institute of Hope & Innovation90603WhittierCalifornia
Florida Cancer Specialists (FCS) South33901Fort MyersFlorida
Asclepes Research Centers - Weeki Wachee34607Weeki WacheeFlorida
Northwest Neurology - Rolling Meadows Office60007Elk Grove VillageIllinois
Orchard Healthcare Research Inc.60077SkokieIllinois
Goshen Center for Cancer Care46526GoshenIndiana

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