Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tagraxofusp — DRUG
  9 mcg/kg intravenously Days 1-3
• Azacitidine — DRUG
  75 mg/m2 subcutaneously or intravenously Days 1-7
• Venetoclax — DRUG
  400 mg daily Days 1-21.

Study Details

A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax will begin on Day 4 and continue through Day 24 (21 consecutive days). A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1. Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment, irrespective of hematologic laboratory values. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days (Day 1-3 or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21. A bone marrow biopsy (BM Bx) will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. Subjects who do not achieve a marrow CR (CRm) after Cycle 2 will proceed with the next cycle of Induction Phase study treatment as described above, irrespective of hematologic laboratory values. If a CRm is obtained after Cycle 3 or 4, the subject will move to the Continuation Phase . If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up. If per the investigator, the subject is receiving clinical benefit, study treatment may continue until toxicity or completion of 12 total cycles. A BM Bx will be performed at least every 3 cycles for these subjects.

Key Dates

Start date

May 1, 2024

Status verified

Apr 2026

Primary completion

Jul 21, 2030

Completion

Jul 21, 2031

Study Design

Enrollment

53 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Group
  Each treatment cycle will last 28 days. For Cycle 1, tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax with ramp-up dosing on Day 4 through Day 24. A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1. If a CRm is obtained, the subject will move to the Continuation Phase. Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily (Day 1-3), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21. BM Bx will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up

Primary Outcome Measure

Complete Response [ Time Frame: 5 years ]

Central Contacts

• Joshua Zeidner, MD
  732-236-3903
  [email protected]
• LeaEtta Hyer
  317-634-5842
  [email protected]

Locations (7)

Find similar trials in Miami, FL

Related Studies

• Monitoring Minimal Residual Disease of Patients With Acute Myelogenous Leukemia or High Grade Myelodysplastic Syndrome
  Recruiting · University of Rochester · Rochester, New York
• KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT Children
  PHASE2 · Enrolling By Invitation · Michael Pulsipher · Los Angeles, California
• Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation
  PHASE2 · Recruiting · City of Hope Medical Center · Duarte, California
• A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
  PHASE1 · Recruiting · Orca Biosystems, Inc. · Duarte, California