A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Public ClinicalTrials.gov record NCT02326584. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed.
Study identification
- NCT ID
- NCT02326584
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 116 participants
Conditions and interventions
Conditions
Interventions
- Standard dose cytarabine for induction Drug
- SGN-CD33A Drug
- Daunorubicin Drug
- High dose cytarabine for consolidation Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2014 (Type not available)
- Primary completion
- Jan 30, 2017 (Actual)
- Completion
- Apr 10, 2018 (Actual)
- Last update posted
- May 9, 2018
2014 – 2018
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| City of Hope National Medical Center | Duarte | California | 91010-3000 | — |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | — |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Cleveland Clinic, The | Cleveland | Ohio | 44195 | — |
| James Cancer Hospital / Ohio State University | Columbus | Ohio | 43210 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 30384 | — |
| Charles A. Sammons Cancer Center / Baylor University Medical Center | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02326584, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2018 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02326584 live on ClinicalTrials.gov.