Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06561152
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • Tagraxofusp — DRUG
    Tagraxofusp is administered by intravenous infusion (IV) over 15 minutes for 3 consecutive days of a 28-day cycle. (days 4-6)
  • Cladribine (CLAD) — DRUG
    Cladribine 5mg/m2 IV once daily on days 1-3 (DL1) Cladribine 5mg/m2 IV once daily on days 1-4 (DL2) Cladribine 5mg/m2 IV once daily on days 1-5 (DL3)
  • Cytarabine — DRUG
    Cytarabine 20mg/m2 IV daily days 1-5 (DL1) Cytarabine 20mg/m2 IV daily days 1-7(DL2) cytarabine 20mg/m2 IV daily days 1-10 (DL3)

Study Details

To determine the efficacy of the combination of tagraxofusp, cladribine, and cytarabine.

Key Dates

Start date
Feb 10, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1 (DL1)
    DL1 will consist of cladribine 5mg/m2 IV once daily on days 1-3, cytarabine 20mg/m2 IV daily days 1-5, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
  • Experimental: Dose level 2 (DL2)
    DL2 will consist of cladribine 5mg/m2 IV once daily on days 1-4, cytarabine 20mg/m2 IV daily days 1-7, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
  • Experimental: Dose level 3 (DL3)
    DL3 will consist of cladribine 5mg/m2 IV once daily on days 1-5, cytarabine 20mg/m2 IV daily days 1-10, and tagraxofusp 12 mcg/kg IV daily days 4-6. If a DLT is encountered in the first 2 participants, 3 more will be enrolled at the same dose.
  • Experimental: Dose Level -1 (DL-1)
    DL -1 will consist of cladribine 5mg/m2 IV once daily on days 1-2, cytarabine 20mg/m2 IV daily days 1-4, and tagraxofusp 12mcg/kg IV daily days 4-6.

Primary Outcome Measure

Recommended Phase 2 dose [ Time Frame: up 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Woo In (Yustina) Cho
[email protected]
650-721-2443
Gabriel Mannis (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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