Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Public ClinicalTrials.gov record NCT02152956. 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 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment. Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.
Study identification
- NCT ID
- NCT02152956
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 244 participants
Conditions and interventions
Conditions
Interventions
- Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off Biological
- Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off Biological
- Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off Biological
- Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off Biological
- Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose Biological
- Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose Biological
- Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose Biological
- Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose Biological
- Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose Biological
- Ruxolitinib Drug
- Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose Biological
Biological · 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
- Jun 9, 2014 (Actual)
- Primary completion
- Jul 5, 2022 (Actual)
- Completion
- Jul 5, 2022 (Actual)
- Last update posted
- Jan 30, 2024
2014 – 2022
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | — |
| UCSF - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Georgetown University - Lombardi Cancer Center | Washington D.C. | District of Columbia | 20057 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Loyola University Chicago - Cardinal Bernadin Cancer Center | Maywood | Illinois | 60153 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Stony Brook Medicine | Stony Brook | New York | 11794 | — |
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02152956, 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 Jan 30, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02152956 live on ClinicalTrials.gov.