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Study of Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax for AML

This study is looking at how well two medicines, liposome-encapsulated daunorubicin-cytarabine and venetoclax, work together to treat acute myeloid leukemia (AML). This is a type of blood cancer. The study is for people whose AML has come back after treatment (relapsed), hasn't responded to previous treatments (refractory), or hasn't been treated yet. These drugs are chemotherapy treatments that aim to stop cancer cells from growing, dividing, or spreading. The main goal is to see if participants achieve a complete remission. The study is currently unclear about its recruitment status and plans to enroll 52 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It is a dose-escalation study of venetoclax, but the phase is not specified.
What's involved
Participants will receive liposome-encapsulated daunorubicin-cytarabine intravenously (through a vein) and venetoclax orally (by mouth) for up to 2 cycles during induction and up to 4 cycles during consolidation. Each cycle lasts 28 days.
Compensation
Not stated in the trial record.
Follow-up
The study measures the achievement of complete remission for up to 3 cycles (84 days) and adverse events for up to 28 days.

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NCT03629171

Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~52 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Liposome-encapsulated Daunorubicin-CytarabineVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of composite complete remission
Measured over Up to 3 cycles (84 days)
+1 more outcome measured

Conditions

Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Tapan M Kadia · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Tapan Kadia
[email protected]
713-563-3534
Email the study team

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Eligibility criteria

Inclusion

For the lead in phase: Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible. Patients who have had prior treatment with venetoclax will be allowed to participate in the lead in phase and cohort A
For the dose expansion cohort A (relapsed/refractory \[R/R\] AML): Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible
For the dose expansion cohort B (de novo AML): Patients \>= 18 years to 69 years of age; patients in this cohort must have received no prior therapy for AML
Prior therapy with hydroxyurea, hematopoietic growth factors, or tretinoin (ATRA) (for emergency use for stabilization) is allowed with no washout. A cumulative dose of ara-C of up to 3 g for emergency stabilization in patients with rapidly proliferating disease is also allowed provided it was administered \> 48 hrs prior to enrollment
Bilirubin =\< 2 mg/dL
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) or \< 5 x ULN if related to leukemic involvement
Creatinine =\< 1.5 x ULN
Known cardiac ejection fraction of \> or = 45% within the past 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. A woman of childbearing potential is defined as a woman who has not been naturally postmenopausal for at least 12 consecutive months, or who had no previous surgical sterilization
Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol

Exclusion

Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided
Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patient with documented hypersensitivity to any of the components of the chemotherapy program
Patients with acute promyelocytic leukemia (M3) or core-binding factor AML
Patients with active central nervous system (CNS) leukemia are excluded since the antileukemia activity of the treatment components against CNS leukemia are not known
Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Prior treatment with CPX-351 or venetoclax. Patients with prior treatment with venetoclax will be allowed in patients with relapsed/refractory (R/R) disease including those in the lead-in phase as well as those in cohort A

What this trial measures

  • Achievement of composite complete remissionUp to 3 cycles (84 days)

    Defined as complete remission/complete remission without blood count recovery/complete remission without platelet recovery. Will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey. Will be estimated along with the 95% credible interval.

  • Incidence of adverse eventsUp to 28 days

    Will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey. Will be summarized using descriptive statistics such as mean, standard deviation, median and range. Safety data will be summarized by category, severity and frequency.