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NCT02404220 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02404220: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT02404220 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02404220, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL). This is a dose escalation study in which after 2 induction cycles participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.
Primary Outcome
The occurrence of any of the following toxicities during Lead-in/Cycle 1 (Day -7 through Day 28) was considered a DLT if judged by the investigator to be possibly, probably, or definitely related to the administration of any drug in the treatment regimen (ENTO, VCR, DEX, institutional standard CNS prophylaxis): * Grade 4 (or higher) non-hematologic toxicity * Grade 3 non-hematologic toxicity lasting ≥ 7 days despite optimal supportive care * Any Grade 3 non-hematologic laboratory value if: *
Interventions
- DRUG Dexamethasone
- DRUG Vincristine
- DRUG Entospletinib
- DRUG CNS Prophylaxis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-05-06 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 1 |
Why NCT02404220 stopped before completion
NCT02404220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT02404220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02404220 about?
NCT02404220 is a clinical study titled "Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)". The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL). This is a dose escalation study in which after 2 ...
What is the current status of trial NCT02404220?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-05-06. Estimated completion is 2018-12-17.
What interventions are being tested in trial NCT02404220?
The interventions under investigation include: Dexamethasone (DRUG), Vincristine (DRUG), Entospletinib (DRUG), CNS Prophylaxis (DRUG).
Who is sponsoring clinical trial NCT02404220?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02404220's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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