Trial Outcomes & Findings for Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma (NCT NCT04508647)
NCT ID: NCT04508647
Last Updated: 2024-03-21
Results Overview
Number of subjects that reached a complete response at the end of single agent induction as defined by a Lugano score of 3 or less on arm MONO - Monotherapy: Ublituximab. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake. Patients who did not reach complete response at this point were then bridged to arm COMBO - Combotherapy: Ublituximab + Umbralisib.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
8 weeks post induction
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
Ublituximab Only
Treatment-Naive Stage II (non-contiguous), Stage III, Stage IV FL + MZL will receive Ublituximab 900mg IV weekly x 4 doses. End of treatment assessment 8 weeks post last dose of single agent ublituximab will be performed.
During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes.
|
Ublituximab First, Then Ublituximab and Umbralisib
Patients who achieve less than a complete response will receive a combination of ublituximab and umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1, 8, and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles.
During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.
Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
|
|---|---|---|
|
Cycle 1: Baseline to 8 Weeks
STARTED
|
4
|
0
|
|
Cycle 1: Baseline to 8 Weeks
COMPLETED
|
4
|
0
|
|
Cycle 1: Baseline to 8 Weeks
NOT COMPLETED
|
0
|
0
|
|
Cycle 2: 8 Weeks to 12 Months
STARTED
|
2
|
2
|
|
Cycle 2: 8 Weeks to 12 Months
COMPLETED
|
2
|
2
|
|
Cycle 2: 8 Weeks to 12 Months
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma
Baseline characteristics by cohort
| Measure |
Experimental: Ublituximab
n=2 Participants
Treatment-Naive Stage II (non-contiguous), Stage III, Stage IV FL + MZL will receive Ublituximab 900mg IV weekly x 4 doses. End of treatment assessment 8 weeks post last dose of single agent ublituximab will be performed. administered at 800 mg daily for 12 cycles)
|
Experimental: Ublituximab and Umbralisib
n=2 Participants
Patients who achieve less than a complete response will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1, 8, and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800mg daily for 12 cycles)
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
66 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
60.75 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post inductionNumber of subjects that reached a complete response at the end of single agent induction as defined by a Lugano score of 3 or less on arm MONO - Monotherapy: Ublituximab. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake. Patients who did not reach complete response at this point were then bridged to arm COMBO - Combotherapy: Ublituximab + Umbralisib.
Outcome measures
| Measure |
Ublituximab Only
n=4 Participants
Monotherapy: Ublituximab
|
Ublituximab First, Then Ublituximab and Umbralisib
Patients who achieve less than a complete response on monotherapy Ublituximab will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1,8 and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles)
Ublituximab: Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines.
During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes. During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.
Umbralisib: Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
|
|---|---|---|
|
Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent Induction
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 12 months post inductionNumber of subjects that reached a complete response at up to 12 months post induction as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib. Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake.
Outcome measures
| Measure |
Ublituximab Only
n=2 Participants
Monotherapy: Ublituximab
|
Ublituximab First, Then Ublituximab and Umbralisib
n=2 Participants
Patients who achieve less than a complete response on monotherapy Ublituximab will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1,8 and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles)
Ublituximab: Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines.
During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes. During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.
Umbralisib: Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
|
|---|---|---|
|
Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 12 months post inductionOverall Response Rate for number of subjects as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib. Overall response rate assessed via PET CT utilizing Lugano deauvile criteria where lymphoma lesions had responded and would include complete response, partial response (\> 50% improvement) and stable disease (less than 50 % response)
Outcome measures
| Measure |
Ublituximab Only
n=2 Participants
Monotherapy: Ublituximab
|
Ublituximab First, Then Ublituximab and Umbralisib
n=2 Participants
Patients who achieve less than a complete response on monotherapy Ublituximab will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1,8 and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles)
Ublituximab: Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines.
During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes. During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.
Umbralisib: Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
|
|---|---|---|
|
Overall Response Rates (ORR) for Number of Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Ublituximab Only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ublituximab First, Then Ublituximab and Umbralisib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ublituximab Only
n=2 participants at risk
Treatment-Naive Stage II (non-contiguous), Stage III, Stage IV FL + MZL will receive Ublituximab 900mg IV weekly x 4 doses. End of treatment assessment 8 weeks post last dose of single agent ublituximab will be performed.
Ublituximab: Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines.
During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes.
|
Ublituximab First, Then Ublituximab and Umbralisib
n=2 participants at risk
Patients who achieve less than a complete response will receive a combination of ublituximab AND umbralisib for a total of 12 cycles. (In the combination arm ublituximab will be administered on day 1,8 and 15 on cycle 1 and on day 1 on each cycle thereafter. Umbralisib will be administered at 800 mg daily for 12 cycles)
During combination treatment with umbralisib, ublituximab will be administered over 90 minutes.
Umbralisib: Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
0.00%
0/2 • 15 months, 9 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Blood and lymphatic system disorders
Alanine Aminotransferase Increased
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
General disorders
Back Pain
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Blood and lymphatic system disorders
volare bleeding
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Cardiac disorders
Cardiac Issues
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • 15 months, 9 days
|
100.0%
2/2 • Number of events 4 • 15 months, 9 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 15 months, 9 days
|
100.0%
2/2 • Number of events 2 • 15 months, 9 days
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
General disorders
fatigue
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
100.0%
2/2 • Number of events 2 • 15 months, 9 days
|
|
General disorders
Fever
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Skin and subcutaneous tissue disorders
Mouth Ulcer
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
0.00%
0/2 • 15 months, 9 days
|
|
Hepatobiliary disorders
Elevated Transaminases
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
General disorders
Headache
|
0.00%
0/2 • 15 months, 9 days
|
100.0%
2/2 • Number of events 2 • 15 months, 9 days
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
2/2 • Number of events 2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
General disorders
Nausea
|
0.00%
0/2 • 15 months, 9 days
|
100.0%
2/2 • Number of events 2 • 15 months, 9 days
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
0.00%
0/2 • 15 months, 9 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 2 • 15 months, 9 days
|
|
Renal and urinary disorders
Bilateral kidney pain
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Nervous system disorders
Spasticity
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Ear and labyrinth disorders
Tinnitus
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
0.00%
0/2 • 15 months, 9 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
|
Reproductive system and breast disorders
Vaginal Infection
|
0.00%
0/2 • 15 months, 9 days
|
50.0%
1/2 • Number of events 1 • 15 months, 9 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place