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Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT04982354
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Baptist Health South Florida

Tracking Information
First Submitted Date  ICMJE July 13, 2021
First Posted Date  ICMJE July 29, 2021
Last Update Posted Date May 3, 2023
Actual Study Start Date  ICMJE July 5, 2022
Estimated Primary Completion Date August 1, 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2021)
  • Change in the complete remission rate [ Time Frame: 3, 6, 12 and 24 months ]
    Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients
  • Change in Progression Free Survival (PFS) [ Time Frame: 3, 6, 12 and 24 months ]
    to determine the PFS of these patients following allo SCT. To estimate PFS the Kaplan-Meier method will be used.
  • Change in Overall Survival (OS) [ Time Frame: 3, 6, 12 and 24 months ]
    to determine the OS of these patients following allo SCT. To estimate OS the Kaplan-Meier method will be used.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2021)
  • Change in the rate of Minimal Residual Disease (MRD) negativity [ Time Frame: 3, 6, 12 and 24 months ]
    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)
  • Correlation of Minimal Residual Disease (MRD) [ Time Frame: 3, 6, 12 and 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • 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.
    Other Name: Rydapt
  • Drug: Busulfan
    0.8 mg/kg/dose every six hours x 12 doses administered intravenously
    Other Name: Myleran
  • Drug: Melphalan
    70 mg/m2/day x 2 doses administered intravenously
    Other Name: Alkeran
  • Drug: Fludarabine
    25 mg/m2/day x 5 doses administered intravenously
    Other Name: Fludara
  • Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
    Allogeneic stem cell transplant infused intravenously
Study Arms  ICMJE Experimental: Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Interventions:
  • Drug: CPX-351
  • Drug: Midostaurin
  • Drug: Busulfan
  • Drug: Melphalan
  • Drug: Fludarabine
  • Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2021)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2032
Estimated Primary Completion Date August 1, 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guenther Koehne, MD, PhD 786-596-2000 GuentherK@Baptisthealth.net
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04982354
Other Study ID Numbers  ICMJE 2019-KOE-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Baptist Health South Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Baptist Health South Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Jazz Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Guenther Koehne, MD. PhD Miami Cancer Institute at Baptist Health of South Florida
PRS Account Baptist Health South Florida
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP