NCT04982354

Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Guenther Koehne · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CPX-351	For this trial, patients will be treated with CPX-351 100 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) for 3 doses on days 1, 3 and 5 of one and on days 1 + 3 of a second cycle of induction therapy, depending on response obtained following the first induction. Thereafter, up to 2 cycles of consolidation therapy of 2 doses on days 1 and 3 of daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 will be administered to the patients.
DRUG	Midostaurin	The FLT3 directed inhibitor, midostaurin, will be given at a dose of 50mg twice daily, starting on day 8 through day 21 of each cycle of CPX-351 until admission for allogeneic stem cell transplant.
DRUG	Busulfan	0.8 mg/kg/dose every six hours x 12 doses administered intravenously
DRUG	Melphalan	70 mg/m2/day x 2 doses administered intravenously
DRUG	Fludarabine	25 mg/m2/day x 5 doses administered intravenously
BIOLOGICAL	CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor	Allogeneic stem cell transplant infused intravenously

Timeline

• Start date: 2022-07-05
• Primary completion: 2031-08-01
• Completion: 2032-08-01
• First posted: 2021-07-29
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study