A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jacqueline Garcia, MD
Study ID
NCT07148180
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Myeloid Leukaemia (AML)
  • Blood Cancer
  • Blood Cancers
  • Leukemia

Eligibility Criteria

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

Interventions

  • Tagraxofusp — DRUG
    A CD123-directed cytotoxin, Single-use vial, via intravenous (into the vein) infusion per protocol.
  • Azacitidine (AZA) — DRUG
    A cytidine nucleoside analog, single-use vial, via intravenous infusion or subcutaneous (under the skin) injection per standard of care.
  • Venetoclax — DRUG
    A BCL-2 inhibitor, tablet, via orally per standard of care.

Study Details

The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence. The names of the study drugs involved in this study are: * Tagraxofusp (a type of CD123-directed cytotoxin) * Azacitidine (a type of standard of care cytidine nucleoside analog) * Venetoclax (a type of standard of care BCL-2 inhibitor)

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Arm 1: Phase 1 Dose Escalation
    Up to 12 participants will be enrolled in a standard 3+3 design to determine the maximum tolerated dose/RP2D for Tagraxofusp in combination with azacitidine and venetoclax starting at Dose Level 1 and escalating to Dose Level 2 according to dose-limiting toxicity rules. * Baseline visit * Cycles 1 through 2 (28 day cycles): * Days 1 through 7: Predetermined dose of Azacitidine 1x daily. * Days 4 through 6: Predetermined dose of Tagraxofusp 1x daily. * Days 1 and 14: Predetermined dose of Venetoclax 1x daily * Day 28: bone marrow aspiration and biopsy * Cycles 3 through 24 (28 day cycles): * Days 1 through 7: Predetermined dose of Azacitidine 1x daily. * Days 4 through 6: Predetermined dose of Tagraxofusp 1x daily. * Days 1 and 14: Predetermined dose of Venetoclax 1x daily * Bone marrow aspirations/biopsies on Day 1 of Cycles 4, 6, 9, 12, and then every 3 cycles. * End of treatment visit with bone marrow aspiration and biopsy * Follow up for up to 2 years
  • Experimental: Arm 2: Phase 2 Dose Expansion
    19 Participants will receive Tagraxofusp at the RP2D in combination with Azacitidine and Venetoclax and will complete: * Baseline visit * Cycles 1 through 2 (28 day cycles): * Days 1 through 7: Predetermined dose of Azacitidine 1x daily. * Days 4 through 6: Predetermined dose of Tagraxofusp 1x daily. * Days 1 and 14: Predetermined dose of Venetoclax 1x daily * Day 28: bone marrow aspiration and biopsy * Cycles 3 through 24 (28 day cycles): * Days 1 through 7: Predetermined dose of Azacitidine 1x daily. * Days 4 through 6: Predetermined dose of Tagraxofusp 1x daily. * Days 1 and 14: Predetermined dose of Venetoclax 1x daily * Bone marrow aspirations/biopsies on Day 1 of Cycles 4, 6, 9, 12, and then every 3 cycles. * End of treatment visit with bone marrow aspiration and biopsy * Follow up for up to 2 years

Primary Outcome Measure

Recommended phase II dose (RP2D) of tagraxofusp in combination with fixed dose of Azacitidine and Venetoclax [Phase I] [ Time Frame: Up to 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Jacqueline S Garcia, MD
[email protected]
617-632-6349
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jacqueline Garcia, MD
[email protected]
617-632-6349
Jacqueline Garcia, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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