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

Part of paid clinical trials in Duarte, California.

Sponsor
MacroGenics
Study ID
NCT02152956
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
  • Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
  • Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
  • Ruxolitinib — DRUG
    Oral inhibitor of JAK kinase
  • Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose — BIOLOGICAL
    Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

Study Details

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.

Key Dates

Start date
Jun 9, 2014
Status verified
Jan 2024
Primary completion
Jul 5, 2022
Completion
Jul 5, 2022

Study Design

Enrollment
244 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 0-a
  • Experimental: Cohort 0-b
  • Experimental: Cohort 0-c
  • Experimental: Cohort 0-d
  • Experimental: Cohort 1
  • Experimental: Cohort 2
  • Experimental: Cohort 2a
  • Experimental: Cohort 3
  • Experimental: Cohort 6
  • Experimental: Cohort 7
  • Experimental: Cohort 8
  • Experimental: MTD Expansion
  • Experimental: MTD expansion with Ruxolitinib

Primary Outcome Measure

Efficacy Based on CR or CRh Rate [ Time Frame: up to 14 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
UCSD Moores Cancer CenterLa JollaCalifornia92093-
UCSF - Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
University of California, San FranciscoSan FranciscoCalifornia94143-
Georgetown University - Lombardi Cancer CenterWashington D.C.District of Columbia20057-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Loyola University Chicago - Cardinal Bernadin Cancer CenterMaywoodIllinois60153-
University of MarylandBaltimoreMaryland21201-
University of MichiganAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Stony Brook MedicineStony BrookNew York11794-
University of North Carolina Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Providence Portland Medical CenterPortlandOregon97213-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

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By research site
City of Hope National Medical Center· Duarte, CAUCSD Moores Cancer Center· La Jolla, CAUCSF - Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUniversity of California, San Francisco· San Francisco, CAGeorgetown University - Lombardi Cancer Center· Washington D.C., DCMoffitt Cancer Center· Tampa, FL

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