Trial Outcomes & Findings for APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL) (NCT NCT04419389)
NCT ID: NCT04419389
Last Updated: 2025-03-17
Results Overview
The occurrence of DLTs, classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events .
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Through study completion, approximately 1 year
Results posted on
2025-03-17
Participant Flow
No patients were enrolled in Safety Lead-In Cohort 1, Safety Lead-In Cohort 3, and Expansion Phase.
Participant milestones
| Measure |
Safety Lead-In Cohort 2
APR-246 + Venetoclax + Rituximab in Subjects with R/R CLL.
APR-246 (eprenetapopt) + Venetoclax + Rituximab in CLL: APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)
Baseline characteristics by cohort
| Measure |
Safety Lead-In Cohort 2
n=1 Participants
APR-246 + Venetoclax + Rituximab in Subjects with R/R CLL.
APR-246 (eprenetapopt) + Venetoclax + Rituximab in CLL: APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
|
|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 1 yearPopulation: Data was not collected as study was terminated.
The occurrence of DLTs, classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events .
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, approximately 6 monthsPopulation: Study was terminated.
The frequency of TEAEs and SAEs related to APR-246 in combination with acalabrutinib and with venetoclax + rituximab therapy
Outcome measures
| Measure |
Safety Lead-In Cohort 2
n=1 Participants
APR-246 + Venetoclax + Rituximab in Subjects with R/R CLL.
APR-246 (eprenetapopt) + Venetoclax + Rituximab in CLL: APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
|
|---|---|
|
To Assess the Frequency of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Related to APR-246 in Combination With Acalabrutinib and With Venetoclax + Rituximab Therapy.
|
1 participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 1 yearPopulation: Data was not collected as study was terminated.
The highest dose of APR-246 with acceptable toxicity (RP2D of APR-246) (the dose producing ≤ 20% of DLT).
Outcome measures
Outcome data not reported
Adverse Events
Safety Lead-In Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Lead-In Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Expansion Cohorts
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety Lead-In Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Safety Lead-In Cohort 1
APR-246 + Acalabrutinib in Subjects with R/R CLL.
APR-246 (eprenetapopt) + Acalabrutinib in CLL: APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule
|
Safety Lead-In Cohort 2
n=1 participants at risk
APR-246 + Venetoclax + Rituximab in Subjects with R/R CLL.
APR-246 (eprenetapopt) + Venetoclax + Rituximab in CLL: APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
|
Expansion Cohorts
APR-246 + (Acalabrutinib, OR, (Ven+R)) in Subjects with R/R TP53-mutant CLL, and/or MCL, and/or RT
APR-246 (eprenetapopt) + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT: APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule Venetoclax and Rituxiab will be given at a standard dose and schedule
|
Safety Lead-In Cohort 3
APR-246 + Venetoclax + Rituximab in Subjects with RT
APR-246 (eprenetapopt) + Venetoclax + Rituximab in RT: APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • Number of events 3 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Investigations
Blood Bilirubin Increased
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • Number of events 4 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
General disorders
Odema Peripheral
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
General disorders
Hyperphosphatemia
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness Lower Limb
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
General disorders
Pain
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
100.0%
1/1 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
—
0/0 • approximately up to 6 months
Study terminated after 1 patient was enrolled in cohort 2. No patients were enrolled in Cohort 1, Cohort 3 and the expansion Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60