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NCT01994382 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
NCT01994382: Completed Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT01994382 is a Phase 1 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 260 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01994382, a Phase 1 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
Study Summary
This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
Primary Outcome
DLT was defined as any of the following toxicities, possibly or probably related to cerdulatinib, and clinically significant (in the judgement of Investigator): -Febrile neutropenia (absolute neutrophil count \<1000/microliter \[μL\] and temperature ≥38.5°Celcius). -Grade 4 neutropenia for \>5 days. -Grade 4 thrombocytopenia with or without bleeding. -Grade 3 thrombocytopenia with bleeding. -Grade 4 anemia, unexplained by underlying disease. -Grade 3 or greater nausea, vomiting, or diarrhea if p
Interventions
- BIOLOGICAL Rituximab
- DRUG Cerdulatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2013-08-30 |
| Est. Completion | 2020-12-15 |
| Phase | Phase 1 |
What the finished NCT01994382 record still lists
NCT01994382 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01994382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01994382 about?
NCT01994382 is a clinical study titled "Phase 1/2a Dose Escalation Study in Participants With CLL, SLL, or NHL". This study will identify the highest dose, and assess the safety, of cerdulatinib (PRT062070) that may be given in participants with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or non-hodgkin lymphoma.
What is the current status of trial NCT01994382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2013-08-30. Estimated completion is 2020-12-15.
What interventions are being tested in trial NCT01994382?
The interventions under investigation include: Rituximab (BIOLOGICAL), Cerdulatinib (DRUG).
Who is sponsoring clinical trial NCT01994382?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01994382's enrollment target sits among peer trials
260 160th of 2000 higher than 1,834 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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