Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients gre

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • EA4181
    NCT ID
    • NCT04115631
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Dipenkumar
      Modi, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Endpoints & Objectives
    • PET/CT CR/Peripheral blood MRD negative rate

    Secondary Endpoints
    • Progressionfree survival at 36 months
    • Toxicity rates (incidence of Grade 3/4 infections, renal and neurologic toxicities, cumulative dose of cytarabine & acalabrutinib, dose reduction, and treatment discontinuation due to toxicity)
    • Objective response rate (ORR)
    • Overall survival at 36 months
    • Mobilization failure rate (defined as a yield less than 2x10^6 CD34+ stem cells/kg with a maximum of 4 courses of apheresis)
    • To compare PET/CT negative rate between the three arms
    • To evaluate the association between baseline PET quantitative assessment (qPET) and MRD status at EOT
    • To evaluate the association between the change of qPET parameters from baseline to EOT and MRD, and compare this association across all 3 arms
    • To determine the incremental prognostic value of baseline qPET to standard risk markers (MIPI) in predicting MRD status at EOT
    • To determine the prognostic value of baseline, interim and EOT PET in predicting PFS
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266