A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acu… (NCT04209725) | Clinical Trial Compass
TerminatedPhase 2
A Study of CPX-351 (Vyxeosâ„¢) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
Stopped: Closed due to slow enrollment
United States1 participantsStarted 2020-06-03
Plain-language 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 Vyxeosâ„¢), 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent form (ICF), according to local guidelines, signed by the patient or by a legal guardian prior to the performance of any study-related screening procedures.
✓. Patients with the following types of AML with \>5% blasts:
✓. First-line therapy must have contained a standard induction chemotherapy (e.g. 7+3, FLAG-IDA, FLAG, CLAG, MEC, hypomethylating agent with venetoclax) with or without receiving a prior FLT3 inhibitor (e.g. midostaurin) or multi-tyrosine kinase inhibitor (e.g. sorafenib). All patients who relapsed after an alloHCT are included, except patients with active graft-versus-host disease (GVHD) requiring \>10 mg prednisone.
✓. Patients must be able to swallow and retain oral medication.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 (Appendix A).
✓. Adequate renal and hepatic parameters (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] ≤2.5 institutional upper limit of normal \[ULN\]; total bilirubin ≤2.0 institutional ULN; serum creatinine \[Cr\] ≤2.0). In patients with suspected liver infiltration, ALT can be ≤5 institutional ULN.
Exclusion criteria
What they're measuring
1
Number of Patients With Treatment Related Adverse Events After Taking CPX-351 and Quizartinib
Timeframe: Collected during treatment and for 30 days after last dose, approximately 35 total days for the 1 patient treated.
2
Number of Patients With an Overall Response Taking CPX-351 and Quizartinib
Timeframe: from cycle 1 day 1 (each cycle is 28 days) until disease progression for up to 2 years post treatment
✕. Female patients who are lactating or have a positive serum pregnancy test during the screening period. Female patients of childbearing potential who are not willing to employ highly effective birth control (as defined in Appendix C of protocol) from screening to 6 months following the last dose of CPX-351 and/or quizartinib.
✕. Evidence of active and uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of active infection progression are present. This is assessed by the site clinicians, including an infectious disease consulting physician, if requested by the Principal Investigator (PI), regarding adequacy of therapy. These infections include, but are not limited to:
✕. History of hypersensitivity to cytarabine, daunorubicin, or an FLT3 inhibitor
✕. Any patients with known significant impairment in gastrointestinal (GI) function or GI disease that my significantly alter the absorption of quizartinib.
✕. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
✕. Uncontrolled or significant cardiovascular disease, including any of the following:
✕. History of New York Heart Association Class 3 or 4 heart failure