Clinical Trials Logo

Clinical Trial Summary

This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia (AML) that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD). This study is to learn more about an investigational drug, quizartinib, being tested with the anti-cancer medicine CPX-351 (also called Vyxeos™), which is approved and widely used to treat AML. The purpose of this study is to assess the safety, tolerability and survival of patients receiving the combination of CPX-351 and quizartinib.


Clinical Trial Description

This is an open-label, two-part Phase II clinical trial in patients with relapsed or refractory FLT3-ITD mutation-positive acute myeloid leukemia (AML). The study is designed to assess the safety and tolerability as well as the efficacy of administering CPX-351 (cytarabine:daunorubicin liposome complex) with quizartinib. CPX-351 is a formulation of two drugs, cytarabine and daunorubicin, that is administered as the first part of treatment to get rid of as many leukemia cells in your bone marrow as possible. Quizartinib is an investigational drug made of a protein that inhibits FLT3 and will be given after CPX-351 has been given. The plan for administration is divided into three phases: induction, consolidation, and maintenance. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04209725
Study type Interventional
Source SCRI Development Innovations, LLC
Contact
Status Terminated
Phase Phase 2
Start date June 3, 2020
Completion date April 20, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05319587 - Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Active, not recruiting NCT04090736 - Study to Compare Azacitidine Plus Pevonedistat Versus Azacitidine in Patients With Acute Myeloid Leukemia Not Eligible for Standard Chemotherapy Phase 3
Completed NCT01617226 - Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS Phase 2
Terminated NCT00957580 - Trial of Pimasertib in Hematological Malignancies Phase 2
Terminated NCT00916045 - Pilot Study of Unrelated Cord Blood Transplantation Phase 2
Completed NCT00640796 - Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors Phase 1
Completed NCT00458250 - Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H Phase 1
Active, not recruiting NCT05424380 - A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS Phase 1
Completed NCT01690624 - BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse Phase 1
Recruiting NCT05471700 - Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients Phase 1/Phase 2
Not yet recruiting NCT05016063 - Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Not yet recruiting NCT04450784 - ObServatory Children Acute RElated Therapy Leukemia
Recruiting NCT04265963 - CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Terminated NCT04968860 - Oral Health Condition and Quality of Life in Children With Leukemia
Recruiting NCT03793517 - Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT Phase 2/Phase 3
Terminated NCT02841540 - A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes Phase 1
Recruiting NCT05453903 - A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies Phase 1
Completed NCT03720366 - A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients Phase 1
Withdrawn NCT04230564 - Acute Myeloid Leukemia Real World Treatment Patterns
Terminated NCT03761069 - Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias Phase 1