Actively Recruiting
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-02-20
52
Participants Needed
1
Research Sites
426 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
CONDITIONS
Official Title
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older with relapsed and/or refractory AML are eligible
- Patients aged 18 to 69 years with untreated AML may participate in dose expansion cohort B
- Prior treatment with venetoclax is allowed in the lead-in phase and cohort A
- Prior use of hydroxyurea, hematopoietic growth factors, or tretinoin for emergency stabilization is allowed with no washout
- Emergency stabilization with a cumulative dose of up to 3 g ara-C is allowed if given more than 48 hours before enrollment
- Bilirubin level must be 2 mg/dL or less
- AST and/or ALT must be 3 times the upper limit of normal (ULN) or less, or 5 times ULN if due to leukemic involvement
- Creatinine level must be 1.5 times ULN or less
- Cardiac ejection fraction must be 45% or higher within the past 3 months
- ECOG performance status must be 2 or less
- Negative pregnancy test required within 1 week for women of childbearing potential
- Ability to understand study requirements and provide signed informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with uncontrolled illnesses such as active infections, symptomatic congestive heart failure (NYHA class III or IV), unstable angina, significant cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Known hypersensitivity to any chemotherapy components
- Patients with acute promyelocytic leukemia (M3) or core-binding factor AML
- Patients with active central nervous system leukemia
- Men and women of childbearing potential who do not agree to use contraception during the study
- Prior treatment with CPX-351 or venetoclax, except for venetoclax in the lead-in phase and cohort A
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tapan Kadia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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