Actively Recruiting
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-04-14
38
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, 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
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)
- Patients not eligible for or choosing not to have a stem cell transplant at enrollment
- Intermediate-2 or high-risk MDS or CMML by International Prognostic Scoring System (IPSS) with excess blasts > 5% or 10-19% bone marrow blasts
- No response or relapse after at least 4 cycles of azacitidine, decitabine, guadecitabine, or ASTX727 alone or with investigational agents
- Signed informed consent indicating understanding and willingness to participate
- Total bilirubin less than 3 mg/dL (up to 5 x upper limit if Gilbert's syndrome at investigator discretion)
- AST or ALT less than or equal to 3 times the upper limit of normal (ULN)
- Serum creatinine clearance greater than 30 mL/min without end-stage renal disease
- Use of hydroxyurea or hematopoietic growth factors allowed before or during study as needed
You will not qualify if you...
- New York Heart Association class III or IV congestive heart failure or left ventricular ejection fraction below 50%
- History of myocardial infarction within the last 6 months, unstable angina, or severe uncontrolled ventricular arrhythmias
- Uncontrolled infection not responding to antibiotics
- Pregnant or lactating female patients
- Patients with reproductive potential unwilling to follow contraception requirements during the study
- Positive pregnancy test at screening for females with reproductive potential
- Receiving other investigational agents, chemotherapy, radiotherapy, or immunotherapy within 14 days before study treatment
- Prior cumulative anthracycline exposure over 550 mg/m² daunorubicin or equivalent, or over 400 mg/m² if mediastinal radiation received
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
G
Guillermo M Bravo
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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