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Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

NCT04982354 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2024-10-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Guenther Koehne, MD. PhD · Miami Cancer Institute at Baptist Health of South Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2031-08-01
Completion
2032-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982354 on ClinicalTrials.gov