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

Phase 2

Terminated

• Conditions: Richter Syndrome
• Interventions: Drug: Obinutuzumab; Drug: Ibrutinib; Other: CHOP

• Registration Number: NCT03145480
• Lead Sponsor: Northwell Health

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 Description

Not available

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Study Start: 2017-06-19
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Results First Submitted: 2022-12-27
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Results First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fit arm	CHOP	ibrutinib and obinutuzumab in combination with the CHOP regimen
Fit arm	Obinutuzumab	ibrutinib and obinutuzumab in combination with the CHOP regimen
Frail arm	Ibrutinib	ibrutinib and obinutuzumab
Fit arm	Ibrutinib	ibrutinib and obinutuzumab in combination with the CHOP regimen
Frail arm	Obinutuzumab	ibrutinib and obinutuzumab

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	6 months	ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	6 months	time to progression post treatment of condition
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	health-related quality of life using FACIT Fatigue Scale
Number of Participants With Improved Hemoglobin and Platelet Counts.	6 months	hematologic improvement

Trial Locations

Locations (1)

Northwell Health/CLL Research and Treatment Program; 🇺🇸 New Hyde Park, New York, United States