Clinical Trial: Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Two-arm Phase II Trial Exploring the Use of the Targeted Agents Ibrutinib and Obinutuzumab for the Treatment of Patients With a Diagnosis of Richter's Transformation (RT)

Brief Summary: This research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of CHOP to see how well these drugs work in treating patients with a diagnosis of Richter's Transformation or Richter's Syndrome. The Bruton's Tyrosine Kinase (BTK) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. The monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in Richter's Transformation. Giving ibrutinib with obinutuzumab may be a better treatment for patients with Richter's Transformation. Depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as CHOP (C= cyclophosphamide, H= hydroxydaunorubicin (also called doxorubicin), O= oncovin (also called vincristine, and P= prednisolone or prednisone (corticosteroids).

Detailed Summary:
Sponsor: Northwell Health

Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: 6 months ]

ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with improved hemoglobin and platelet counts. [ Time Frame: 6 months ]
    hematologic improvement
  • Progression free survival (PFS) [ Time Frame: 6 months ]
    time to progression post treatment of condition
  • Quality of Life [ Time Frame: 1 year ]
    health-related quality of life using FACIT Fatigue Scale


Original Secondary Outcome: Same as current

Information By: Northwell Health

Dates:
Date Received: April 4, 2017
Date Started: May 30, 2017
Date Completion: December 2023
Last Updated: May 5, 2017
Last Verified: May 2017