Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
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).
Inclusion Criteria:

 -  confirmed Richter's transformation in treatment naïve and previously treated chronic
 lymphocytic leukemia/small lymphocytic lymphoma patients

 -  may have had prior exposure to ibrutinib and other B-cell signaling receptor agents

 -  Adequate hematologic function

 -  Adequate liver and kidney function

 -  Willing and able to participate in all required evaluations and procedures in this
 study protocol

 -  Female subjects of childbearing potential must not be pregnant upon study entry

 -  Male and female subjects who agree to use highly effective methods of birth control

 Exclusion Criteria:

 -  known allergy to any of medications

 -  chemotherapy taken within 21 days of study treatment

 -  targeted therapy within 10 days of study treatment

 -  BCR inhibitors within 24 hours of study treatment

 -  major surgery within 4 weeks of first dose of study treatment

 -  women who are pregnant

 -  known infection with HIV or Hepatitis C

 -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug