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NCT02029443 · ClinicalTrials.gov registry record · Phase 1
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
A Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Acerta Pharma.
- Active
- Registry status
- Phase 1
- Development phase
- 306
- Enrollment target
- 12
- Study locations
NCT02029443: Active Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Acerta Pharma.
NCT02029443 is a Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Acerta Pharma. The registered enrollment target is 306 participants, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (70% higher). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02029443, a Phase 1 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Acerta Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 306 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Primary Outcome
Participants with DLTs in Phase 1 are reported. The DLT was defined as any of the following events unless the adverse event is clearly related to disease progression or the participant's current medical history and associated comorbidities: (1) Any Grade 3 or greater nonhematologic toxicity with the exceptions of alopecia and Grade 3 nausea, vomiting, and diarrhea that respond to supportive therapy; (2) Hematologic toxicities including Grade 4 neutropenia lasting more than 5 days, Grade 4 or Gra
Conditions Studied
Interventions
- DRUG Acalabrutinib
Study Locations (12)
Other
- Research Site - Milan
- Research Site - Leeds
- Research Site - London
- Research Site - Oxford
New York
- Research Site - New Hyde Park
- Research Site - New York
Washington
- Research Site - Seattle
- Research Site - Tacoma
Massachusetts
- Research Site - Boston
Ohio
- Research Site - Columbus
Texas
- Research Site - Fort Worth
Utah
- Research Site - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2014-01-30 |
| Est. Completion | 2027-06-09 |
| Phase | Phase 1 |
What the registry record for NCT02029443 still lists
NCT02029443 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (70% higher).
The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Acalabrutinib is the first listed.
NCT02029443 lists 12 locations in 7 states (Other, New York, Washington).
Frequently Asked Questions
What is clinical trial NCT02029443 about?
NCT02029443 is a clinical study titled "ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia". This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
What is the current status of trial NCT02029443?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 306 participants. The study started on 2014-01-30. Estimated completion is 2027-06-09.
What conditions does trial NCT02029443 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, Richter's Syndrome.
What interventions are being tested in trial NCT02029443?
The interventions under investigation include: Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT02029443?
This trial is sponsored by Acerta Pharma, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02029443 being conducted?
This trial has 12 study locations across Massachusetts, New York, Ohio, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02029443's enrollment target sits among peer trials
306 28th of 187 higher than 160 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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.
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