Clinical Trials /

Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

NCT04982354

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT04982354

Trial Eligibility

Document

Title

  • Brief Title: Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 2019-KOE-003
  • NCT ID: NCT04982354

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
CPX-351Investigational Treatment
MidostaurinRydaptInvestigational Treatment
BusulfanMyleranInvestigational Treatment
MelphalanAlkeranInvestigational Treatment
FludarabineFludaraInvestigational Treatment
CD34+ selected allogeneic stem cell transplant from an HLA-compatible donorInvestigational Treatment

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Investigational TreatmentExperimentalDaunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
  • CPX-351
  • Midostaurin
  • Busulfan
  • Melphalan
  • Fludarabine
  • CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor

Eligibility Criteria

        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).
Maximum Eligible Age:74 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in the complete remission rate
Time Frame:3, 6, 12 and 24 months
Safety Issue:
Description:Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients

Secondary Outcome Measures

Measure:Change in the rate of Minimal Residual Disease (MRD) negativity
Time Frame:3, 6, 12 and 24 months
Safety Issue:
Description:Ascertain the rate of MRD negativity by next generation sequencing at sequential time post following induction treatment at complete remission prior to allo Stem Cell Transplantation (SCT)
Measure:Correlation of Minimal Residual Disease (MRD)
Time Frame:3, 6, 12 and 24 months
Safety Issue:
Description:Correlation of duration of MRD negative status with duration of complete remission of these patients will be assessed using Spearman's correlation with reported p value.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Baptist Health South Florida

Last Updated

July 29, 2021