Trial Outcomes & Findings for Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma (NCT NCT02204982)
NCT ID: NCT02204982
Last Updated: 2023-09-28
Results Overview
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
Until disease progression, for up to 5 years from randomization
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Duvelisib + Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Placebo + Rituximab
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Duvelisib + Rituximab
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Placebo + Rituximab
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
|---|---|---|
|
Overall Study
Patient ineligible-medical monitor
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Adverse Event and Investigator decision
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol-Specified Disease Progression
|
0
|
4
|
|
Overall Study
Termination of Study bySponsor
|
0
|
1
|
Baseline Characteristics
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Duvelisib + Rituximab
n=6 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Placebo + Rituximab
n=7 Participants
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Total
n=13 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0=Fully active, no restrictions
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1= Restricted in physically strenuous activity
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
2=Ambulatory more than 50% of waking hours
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
3=Confined to bed or chair more than 50% of waking
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
4=Completely disabled
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
5=Dead
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, for up to 5 years from randomizationPopulation: Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.
Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until disease progression, for up to 5 years from randomizationOutcome measures
| Measure |
Duvelisib + Rituximab
n=5 Participants
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Placebo + Rituximab
n=6 Participants
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
|---|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
3 Participants
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
2 Participants
|
1 Participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
0 Participants
|
3 Participants
|
|
Overall Response Rate (ORR)
Progressive Disease
|
0 Participants
|
2 Participants
|
Adverse Events
Duvelisib + Rituximab
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo + Rituximab
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duvelisib + Rituximab
n=6 participants at risk
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Placebo + Rituximab
n=7 participants at risk
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
33.3%
2/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
33.3%
2/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
General disorders
Pyrexia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive pulmonary disease
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
Other adverse events
| Measure |
Duvelisib + Rituximab
n=6 participants at risk
Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Duvelisib: duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
Placebo + Rituximab
n=7 participants at risk
Placebo is administered orally and supplied as formulated capsules to match the active 5 mg and 25 mg capsules.
Rituximab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg and 500 mg.
Placebo: Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
Rituximab: IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • 15 months
|
28.6%
2/7 • 15 months
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Amylase increased
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Blood Cholesterol increased
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Lipase increased
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Weight increased
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Investigations
Blood Uric acid increased
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • 15 months
|
28.6%
2/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Mouth Ulceration
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
General disorders
Asthenia
|
33.3%
2/6 • 15 months
|
28.6%
2/7 • 15 months
|
|
General disorders
Chest pain
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
General disorders
Pyrexia
|
16.7%
1/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
General disorders
Chills
|
0.00%
0/6 • 15 months
|
28.6%
2/7 • 15 months
|
|
General disorders
Fatigue
|
0.00%
0/6 • 15 months
|
28.6%
2/7 • 15 months
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • 15 months
|
28.6%
2/7 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • 15 months
|
0.00%
0/7 • 15 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/6 • 15 months
|
14.3%
1/7 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place