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NCT02152956 · ClinicalTrials.gov registry record · Phase 1
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by MacroGenics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 244
- Enrollment target
NCT02152956: Clinical Trial Phase 1 study, sponsored by MacroGenics.
NCT02152956 is a Phase 1 study that was terminated before completion, run by MacroGenics. The registered enrollment target is 244 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (307% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152956, a Phase 1 study, was terminated before completion, sponsored by MacroGenics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 244 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Proportion of patients achieving a best response of CR (morphologic CR \[mCR\], cytogenetic CR \[CRc\], molecular CR \[CRm\], or CRh per Interworking Group AML response criteria. CR is defined as mCR, CRc, CRm or CRh. mCR is defined as: normal. neutrophil and platelet counts, less than 5% blast cells in a bone marrow (BM) smear and. no extramedullary disease. CRc is defined as: CR with no evidence of cytogenetic abnormalities in the bone marrow. CRm is defined as: CR with no evidence of molec
Interventions
- BIOLOGICAL 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2014-06-09 |
| Est. Completion | 2022-07-05 |
| Phase | Phase 1 |
Why NCT02152956 stopped before completion
NCT02152956 is an interventional study that assigns participants to a tested intervention. The registered 244 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 (307% higher).
The record links to 0 conditions, and to 5 interventions - of which Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off is the first listed.
NCT02152956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02152956 about?
NCT02152956 is a clinical study titled "Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)". 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)....
What is the current status of trial NCT02152956?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2014-06-09. Estimated completion is 2022-07-05.
What interventions are being tested in trial NCT02152956?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT02152956?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02152956's enrollment target sits among peer trials
244 191st of 2000 higher than 1,808 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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