Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
Primary Purpose
Richter Syndrome
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obinutuzumab
Ibrutinib
CHOP
Sponsored by
About this trial
This is an interventional treatment trial for Richter Syndrome focused on measuring leukemia, richter
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
Sites / Locations
- Northwell Health/CLL Research and Treatment Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fit arm
Frail arm
Arm Description
ibrutinib and obinutuzumab in combination with the CHOP regimen
ibrutinib and obinutuzumab
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Secondary Outcome Measures
Number of Participants With Improved Hemoglobin and Platelet Counts.
hematologic improvement
Progression Free Survival (PFS)
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)
health-related quality of life using FACIT Fatigue Scale
Full Information
NCT ID
NCT03145480
First Posted
April 4, 2017
Last Updated
May 30, 2023
Sponsor
Northwell Health
Collaborators
Pharmacyclics LLC.
1. Study Identification
Unique Protocol Identification Number
NCT03145480
Brief Title
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Investigator decision to close study
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
Pharmacyclics LLC.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Richter Syndrome
Keywords
leukemia, richter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment based on fitness of participants
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fit arm
Arm Type
Experimental
Arm Description
ibrutinib and obinutuzumab in combination with the CHOP regimen
Arm Title
Frail arm
Arm Type
Experimental
Arm Description
ibrutinib and obinutuzumab
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
gazyva
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
imbruvica
Intervention Description
560mg po daily
Intervention Type
Other
Intervention Name(s)
CHOP
Other Intervention Name(s)
CHOP Regimen
Intervention Description
cyclophosphamide, doxorubicin, vincristine, and prednisone
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Improved Hemoglobin and Platelet Counts.
Description
hematologic improvement
Time Frame
6 months
Title
Progression Free Survival (PFS)
Description
time to progression post treatment of condition
Time Frame
6 months
Title
To Evaluate Patient-reported Outcome (PRO) of Health-related Quality of Life by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACiT-Fatigue)
Description
health-related quality of life using FACIT Fatigue Scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Barrientos, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health/CLL Research and Treatment Program
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
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