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NCT04419389 · ClinicalTrials.gov registry record · Phase 1
APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)
A Phase 1 study, sponsored by Aprea Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04419389: Clinical Trial Phase 1 study, sponsored by Aprea Therapeutics.
NCT04419389 is a Phase 1 study that was terminated before completion, run by Aprea Therapeutics. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04419389, a Phase 1 study, was terminated before completion, sponsored by Aprea Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 in combination with either acalabrutinib or venetoclax + rituximab therapy in subjects with NHL, including relapsed and/or refractory (R/R) CLL and R/R MCL.
Primary Outcome
The occurrence of DLTs, classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events .
Interventions
- DRUG APR-246 (eprenetapopt) + Acalabrutinib in CLL
- DRUG APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in CLL
- DRUG APR-246 (eprenetapopt) 4.5 g/d + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT
- DRUG APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in RT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2021-08-24 |
| Phase | Phase 1 |
Why NCT04419389 stopped before completion
NCT04419389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which APR-246 (eprenetapopt) + Acalabrutinib in CLL is the first listed.
NCT04419389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04419389 about?
NCT04419389 is a clinical study titled "APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL)". Study to determine the preliminary safety, tolerability, and pharmacokinetic (PK) profile of APR-246 in combination with either acalabrutinib or venetoclax + rituximab therapy in subjects with NHL, including relapsed and/or refractory (R/R) CLL and R/R MCL.
What is the current status of trial NCT04419389?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2021-03-02. Estimated completion is 2021-08-24.
What interventions are being tested in trial NCT04419389?
The interventions under investigation include: APR-246 (eprenetapopt) + Acalabrutinib in CLL (DRUG), APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in CLL (DRUG), APR-246 (eprenetapopt) 4.5 g/d + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT (DRUG), APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in RT (DRUG).
Who is sponsoring clinical trial NCT04419389?
This trial is sponsored by Aprea Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04419389's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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