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) or Richter's Syndrome (RS)
Overview
- Phase
- Phase 2
- Intervention
- Obinutuzumab
- Conditions
- Richter Syndrome
- Sponsor
- Northwell Health
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Overall Response Rate (ORR)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Fit arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
Intervention: Obinutuzumab
Fit arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
Intervention: Ibrutinib
Fit arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
Intervention: CHOP
Frail arm
ibrutinib and obinutuzumab
Intervention: Obinutuzumab
Frail arm
ibrutinib and obinutuzumab
Intervention: Ibrutinib
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: 6 months
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Secondary Outcomes
- Progression Free Survival (PFS)(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)(1 year)
- Number of Participants With Improved Hemoglobin and Platelet Counts.(6 months)