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Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

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

NCT04982354•Guenther Koehne

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have a Karnofsky (adult) Performance Status of at least 70%.
•Patients must have adequate organ function

Exclusion Criteria

•Female patients who are pregnant or breast-feeding
•Active viral, bacterial or fungal infection
•Patient seropositive for Human Immunodeficiency Virus (HIV-I /II); Human T-Cell Lymphotrophic Virus (HTLV -I /II)
•Presence of leukemia in the Central Nervous System (CNS).

Locations (1)

Miami Cancer Institute at Baptist Health of South Florida

Miami, Florida, United States

Key Dates

Start Date

July 5, 2022

Primary Completion Date

August 1, 2031

Completion Date

August 1, 2032

Last Updated

October 1, 2024

Conditions

Acute Myeloid Leukemia

Interventions

CPX-351

DRUG

Midostaurin

DRUG

Busulfan

DRUG

Melphalan

DRUG

Fludarabine

DRUG

CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor

BIOLOGICAL

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

NCT06220162

Acute Myeloid Leukemia

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

NCT04065399

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias