Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
NCT ID: NCT04982354
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-07-05
2032-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
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.
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.
Busulfan
0.8 mg/kg/dose every six hours x 12 doses administered intravenously
Melphalan
70 mg/m2/day x 2 doses administered intravenously
Fludarabine
25 mg/m2/day x 5 doses administered intravenously
CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Allogeneic stem cell transplant infused intravenously
Interventions
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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.
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.
Busulfan
0.8 mg/kg/dose every six hours x 12 doses administered intravenously
Melphalan
70 mg/m2/day x 2 doses administered intravenously
Fludarabine
25 mg/m2/day x 5 doses administered intravenously
CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Allogeneic stem cell transplant infused intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have adequate organ function
Exclusion Criteria
* 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).
18 Years
74 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Guenther Koehne
OTHER
Responsible Party
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Guenther Koehne
Deputy Director and Chief of Blood and Marrow Transplant, Hematologic Oncology and Benign Hematology
Principal Investigators
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Guenther Koehne, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute at Baptist Health of South Florida
Locations
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Miami Cancer Institute at Baptist Health of South Florida
Miami, Florida, United States
Countries
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Related Links
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Miami Cancer Institute Website
Other Identifiers
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2019-KOE-003
Identifier Type: -
Identifier Source: org_study_id
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