Trial Outcomes & Findings for Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients (NCT NCT03145480)
NCT ID: NCT03145480
Last Updated: 2023-06-01
Results Overview
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-01
Participant Flow
Participant milestones
| Measure |
Fit Arm
ibrutinib and obinutuzumab in combination with the CHOP regimen
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
CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone
|
Frail Arm
ibrutinib and obinutuzumab
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
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fit Arm
n=3 Participants
ibrutinib and obinutuzumab in combination with the CHOP regimen
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
CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone
|
Frail Arm
ibrutinib and obinutuzumab
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
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>= 18 Years
|
3 Participants
n=3 Participants
|
0 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
0 Participants
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
0 Participants
|
1 Participants
n=3 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: No data was collected for this outcome measure.
ORR in subjects treated with combination of ibrutinib and obinutuzumab (with or without CHOP)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: No data was collected for this outcome measure.
hematologic improvement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: No participants were enrolled into the Frail Arm. No data was collected for the Frail Arm, there are no results to report. Data reported for the Fit Arm is estimated.
time to progression post treatment of condition
Outcome measures
| Measure |
Fit Arm
n=3 Participants
ibrutinib and obinutuzumab in combination with the CHOP regimen
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
CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone
|
Frail Arm
ibrutinib and obinutuzumab
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
|
|---|---|---|
|
Progression Free Survival (PFS)
|
23.5 Months
Standard Deviation 1.9
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No data was collected for this outcome measure.
health-related quality of life using FACIT Fatigue Scale
Outcome measures
Outcome data not reported
Adverse Events
Fit Arm
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Frail Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fit Arm
n=3 participants at risk
ibrutinib and obinutuzumab in combination with the CHOP regimen
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
CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone
|
Frail Arm
ibrutinib and obinutuzumab
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
|
|---|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
Other adverse events
| Measure |
Fit Arm
n=3 participants at risk
ibrutinib and obinutuzumab in combination with the CHOP regimen
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
CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone
|
Frail Arm
ibrutinib and obinutuzumab
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
|
|---|---|---|
|
Nervous system disorders
peripheral neuropathy
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Gastrointestinal disorders
constipation
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
100.0%
3/3 • Number of events 3 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
General disorders
fatigue
|
100.0%
3/3 • Number of events 3 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 2 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Metabolism and nutrition disorders
hypokalemia
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Gastrointestinal disorders
diarrhea
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Investigations
Alkaline phosphatase elevated
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Investigations
ALT increased
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
|
Investigations
AST increased
|
33.3%
1/3 • Number of events 1 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
—
0/0 • 1 year and 3 months
No subjects were randomized to the Frail Arm, therefore no subjects were at risk for Adverse Events in this arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place