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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6
560mg po daily
cyclophosphamide, doxorubicin, vincristine, and prednisone
Northwell Health/CLL Research and Treatment Program
New Hyde Park, New York, United States
Overall Response Rate (ORR)
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Time frame: 6 months
Number of Participants With Improved Hemoglobin and Platelet Counts.
hematologic improvement
Time frame: 6 months
Progression Free Survival (PFS)
time to progression post treatment of condition
Time frame: 6 months
To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)
health-related quality of life using FACIT Fatigue Scale
Time frame: 1 year
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