Clinical trial for Blasts More Than 5 Percent of Bone Marrow Nucleated Cells
Official title Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction
ClinicalTrials.gov ID: NCT04049539
What this study is testing
What is Liposome-encapsulated Daunorubicin-Cytarabine?
Liposome-encapsulated Daunorubicin-Cytarabine is an investigational medicine, given as a once-weekly IV infusion (through a vein), being studied as a potential treatment for blasts more than 5 percent of bone marrow nucleated cells.
Also referred to as CPX-351, Cytarabine-Daunorubicin Liposome for Injection.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Subject must be able to provide written informed consent
- Patients must have a diagnosis of acute myeloid leukemia
- Patients must have received standard induction chemotherapy (cytarabine 100-200mg/m2 by continuous infusion on days 1-7 and either daunorubicin...
- Patients must be deemed by the treating physician to be unlikely to achieve complete response (CR) without further therapy
- Patients must be deemed by the treating physician to be able to tolerate intensive chemotherapy (similar to 7+3 chemotherapy)
You likely can't join if
- Acute promyelocytic leukemia (or M3 AML)
- Patients known to have core binding factor AML (defined as presence of t(8;21), inv(16), or other cytogenetically equivalent abnormalities)
- Patients known to have inactivating mutations of TP53 or evidence of an absence of p53 protein activity as indicated by a monosomal karyotype.
- Patients that the treating physician does not feel are able to tolerate intensive chemotherapy
- History of serious (\>= grade 3) hypersensitivity reaction to cytarabine, daunorubicin, or any component of the formulation
- Known Wilson's disease or other symptomatic abnormality of copper metabolism (laboratory screening is not required in the absence of clinical or...
See the full eligibility criteria
- Subject must be able to provide written informed consent
- Patients must have a diagnosis of acute myeloid leukemia
- Patients must have received standard induction chemotherapy (cytarabine 100-200mg/m2 by continuous infusion on days 1-7 and either daunorubicin 45-90mg/m2 or idarubicin 10-12mg/ m2 daily for 3 days during days 1-7)...
- Patients must be deemed by the treating physician to be unlikely to achieve complete response (CR) without further therapy
- Patients must be deemed by the treating physician to be able to tolerate intensive chemotherapy (similar to 7+3 chemotherapy)
- Normal left ventricular ejection fraction (\>= 50% by echocardiography or multi-gated acquisition radionuclide angiocardiography [MUGA]) and lifetime daunorubicin dose of less than 462mg/m\^2 (including recent course of...
- Eastern Cooperative Oncology Group (ECOG) functional status of 0, 1, or 2
- Aspartate aminotransferase (AST) \< 5 x upper limit of normal (ULN) for the local laboratory
- Alanine aminotransferase (ALT) \< 5 x ULN for the local laboratory
- Total bilirubin \< 1.5 x ULN (except for patients with known Gilbert?s syndrome) for the local laboratory
- Calculated creatinine clearance (according to the Cockcroft-Gault equation) \> 40 mL/min OR serum creatinine \< 1.5 x the ULN for the local laboratory
- Female patients of childbearing potential must agree to use two forms of contraception from screening visit until 6 months following the last dose of study treatment.
- Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use two forms of contraception from screening...
- Acute promyelocytic leukemia (or M3 AML)
- Patients known to have core binding factor AML (defined as presence of t(8;21), inv(16), or other cytogenetically equivalent abnormalities)
- Patients known to have inactivating mutations of TP53 or evidence of an absence of p53 protein activity as indicated by a monosomal karyotype.
- Patients that the treating physician does not feel are able to tolerate intensive chemotherapy
- History of serious (\>= grade 3) hypersensitivity reaction to cytarabine, daunorubicin, or any component of the formulation
- Known Wilson's disease or other symptomatic abnormality of copper metabolism (laboratory screening is not required in the absence of clinical or historical evidence of Wilson's disease or other problems of copper...
- Total lifetime daunorubicin dose of more than 462 mg/m\^2 (including recent course of 7+3) or equivalent total doses of other anthracycline medications.
- Pregnancy or inability to use highly effective method of contraception for 6 months following last dose of Vyxeos. Potentially fertile patients must have documented negative serum pregnancy test.
- Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.
- Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent and until toxicity from this has resolved to grade 1 or less
- Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
- Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the...
- Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial...
- Other malignancy currently requiring active therapy (except minor surgery for non-melanoma skin cancer and for hormonal/anti-hormonal treatment, e.g. in prostate or breast cancer)
The study team makes the final eligibility decision.
Where it is enrolling
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Columbus, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.