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NCT02614560 · ClinicalTrials.gov registry record · Phase 1
A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients
A Phase 1 study, sponsored by Seagen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02614560: Clinical Trial Phase 1 study, sponsored by Seagen.
NCT02614560 is a Phase 1 study that was terminated before completion, run by Seagen. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02614560, a Phase 1 study, was terminated before completion, sponsored by Seagen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell transplant. The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
Primary Outcome
AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, re
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG vadastuximab talirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-09-14 |
| Phase | Phase 1 |
Why NCT02614560 stopped before completion
NCT02614560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Fludarabine is the first listed.
NCT02614560 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02614560 about?
NCT02614560 is a clinical study titled "A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients". This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy after a stem cell...
What is the current status of trial NCT02614560?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-11. Estimated completion is 2017-09-14.
What interventions are being tested in trial NCT02614560?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), vadastuximab talirine (DRUG).
Who is sponsoring clinical trial NCT02614560?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02614560's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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