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A drug, docirbrutinib, to treat B-cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back (relapsed) or has not gotten better with treatment (refractory) 

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18 and older

Phase 1

13 Locations

NCT05602363

Clinical Trial Goal


To find out:
  • The highest dose of docirbrutinib that’s safe to give 
  • If docirbrutinib is safe and works well to treat B-NHL, CLL, or SLL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have one of the following that is relapsed or refractory: 
    • B-NHL. Some examples include:
      • Follicular lymphoma
      • Mantle cell lymphoma (MCL)
      • Marginal zone lymphoma (MZL)
      • Waldenström macroglobulinemia 
    • CLL
    • SLL
  • Do not have Richter's transformation. Your doctor can tell you this
  • Do not have untreated lymphoma in your brain or spinal cord
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Docirbrutinib is a small molecule inhibitor that blocks BTK in certain cells.
 
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
  • Docirbrutinib – A pill that you take by mouth 2 times each day. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for as long as the clinical trial for as long as the doctor thinks it best for your health. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has approved has not yet approved docirbrutinib.

Contacts


Akinori Arimura, PhD, 650-636-4603, clinical_us@dd.carnabio.com

Locations

UC Irvine HealthRECRUITING

Orange, California
Catherine Coombs, MD, 714-456-8000, ucstudy@hs.uci.edu

Moffitt Cancer CenterRECRUITING

Tampa, Florida
Richard Corona, (813) 745-3465, richard.corona@moffitt.org

Mount Sinai Comprehensive Cancer CenterRECRUITING

Miami Beach, Florida
Yvonne Enriquez, 305-674-2625, yvonne.enriquez@msmc.com

Northwestern Memorial HospitalRECRUITING

Chicago, Illinois
Study Cordinator, (312) 695 1301, cancer@northwestern.edu

American Oncology PartnersRECRUITING

Fort Wayne, Indiana
Phil Hutson, 260-312-2219, phil.hutson@aoncology.com

University of Maryland Medical Center - Greenebaum Comprehensive Cancer CenterRECRUITING

Baltimore, Maryland
Nikki M Glynn-Cunningham, MS, 410-328-7996, nglynn@umm.edu

University of Massachusetts Memorial Medical CenterRECRUITING

Worcester, Massachusetts
UMass Cancer Research Office, 508-856-3216, cancer.research@umassmed.edu

Optum Medical Care PCRECRUITING

Westbury, New York
Jonathan Goldberg, MD, 914-241-1050, jgoldberg@caremount.com

Duke UniversityRECRUITING

Durham, North Carolina
Terri Lucas, 919-681-6580, terri.lucas@duke.edu

Taylor Cancer Research CenterRECRUITING

Maumee, Ohio
Nadine Nemunaitis, 567-402-4501, nnemunaitis@tcrcpt.org

Oncology ConsultantsRECRUITING

Houston, Texas
Contacts:

University of Texas MD Anderson Cancer CenterRECRUITING

Houston, Texas
Nitin Jain, MD, 713-745-6080, njain@mdanderson.org

The Medical College of WisconsinRECRUITING

Milwaukee, Wisconsin
Medical College of Wisconsin Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu

ClinicalTrials.gov record


NCT05602363. First posted on 11/2/22

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