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

Richter Syndrome Clinical Trial

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) or Richter's Syndrome (RS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03145480
• Other study ID #: 16-727
• Status: Terminated
• Phase: Phase 2
• Start date: June 19, 2017
• Est. completion date: September 28, 2018

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Richter Syndrome
• Syndrome

Intervention

Drug:
• Obinutuzumab
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
• Ibrutinib
560mg po daily

Other:
• CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone

Locations

Country	Name	City	State
United States	Northwell Health/CLL Research and Treatment Program	New Hyde Park	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Pharmacyclics LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)	6 months
Secondary	Number of Participants With Improved Hemoglobin and Platelet Counts.	hematologic improvement	6 months
Secondary	Progression Free Survival (PFS)	time to progression post treatment of condition	6 months
Secondary	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	1 year