Terminated PHASE1/PHASE2 INTERVENTIONAL 13-arm NCT02152956

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML) (VOYAGE)

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)

Sponsor: MacroGenics

Conditions AML

Interventions Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose Ruxolitinib

Updated 20 times since 2017 Last updated: Jan 24, 2024 Started: Jun 9, 2014 Primary completion: Jul 5, 2022 Completion: Jul 5, 2022

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Business decision

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Other AML trials with similar outcome

NCT03465540 · Phase PHASE1 · Jul 2019

Browse all AML trials

This PHASE1/PHASE2 trial investigates AML and is currently terminated or withdrawn. MacroGenics leads this study, which shows 20 recorded versions since 2014 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

20 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE1/PHASE2
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Feb 2024 — Jul 2024 [monthly]

Terminated PHASE1_PHASE2
Sep 2022 — Feb 2024 [monthly]

Terminated PHASE1_PHASE2

Status: Active Not Recruiting → Terminated

▶ Show 15 earlier versions

Apr 2022 — Sep 2022 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Jun 2021 — Apr 2022 [monthly]

Recruiting PHASE1_PHASE2
Feb 2021 — Jun 2021 [monthly]

Recruiting PHASE1_PHASE2
Jan 2021 — Feb 2021 [monthly]

Recruiting PHASE1_PHASE2
Nov 2020 — Jan 2021 [monthly]

Recruiting PHASE1_PHASE2
Oct 2020 — Nov 2020 [monthly]

Recruiting PHASE1_PHASE2
May 2020 — Oct 2020 [monthly]

Recruiting PHASE1_PHASE2
Dec 2019 — May 2020 [monthly]

Recruiting PHASE1_PHASE2
Nov 2019 — Dec 2019 [monthly]

Recruiting PHASE1_PHASE2
Jul 2019 — Nov 2019 [monthly]

Recruiting PHASE1_PHASE2
May 2019 — Jul 2019 [monthly]

Recruiting PHASE1_PHASE2

Phase: PHASE1 → PHASE1_PHASE2
Jun 2018 — May 2019 [monthly]

Recruiting PHASE1
Oct 2017 — Jun 2018 [monthly]

Recruiting PHASE1
Feb 2017 — Oct 2017 [monthly]

Recruiting PHASE1
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1

First recorded

Jun 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

MacroGenics

Data source: MacroGenics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Baltimore, United States , Barcelona, Spain , Berlin, Germany , Bologna, Italy , Chapel Hill, United States , Cleveland, United States , Dresden, Germany , Duarte, United States and 32 more locations