OncoMatch/Clinical Trials/NCT03896269
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Is NCT03896269 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Liposome-encapsulated Daunorubicin-Cytarabine for blasts 10-19 percent of bone marrow nucleated cells.
Treatment: Liposome-encapsulated Daunorubicin-Cytarabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Disease stage
Required: Stage INTERMEDIATE-2, HIGH RISK
Prior therapy
Must have received: hypomethylating agent (azacitidine, decitabine, guadecitabine, ASTX727)
No response following at least 4 cycles of therapy or relapse after initial CR, partial response (PR), or HI or progression after any number of cycles of either azacitidine, decitabine, guadecitabine or ASTX727 (oral decitabine) as single agents or in combination with other investigational agents
Cannot have received: anthracycline (daunorubicin)
Prior cumulative anthracycline exposure of > 550 mg/m^2 daunorubicin or equivalent, or > 400 mg/m^2 in patients who received radiation therapy to the mediastinum
Lab requirements
Kidney function
Serum creatinine clearance > 30 mL/min and no end/stage renal disease
Liver function
Total bilirubin < 3 mg/dL (will allow less than 5 x upper limit of normal [ULN] if Gilbert's at investigator's discretion); AST or ALT <= 3 x ULN
Cardiac function
No NYHA class III or IV congestive heart failure; LVEF >= 50% by echocardiogram or MUGA; no history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias
Total bilirubin < 3 mg/dL (will allow less than 5 x upper limit of normal [ULN] if Gilbert's at investigator's discretion); AST or ALT <= 3 x ULN; Serum creatinine clearance > 30 mL/min and no end/stage renal disease; NYHA class III or IV congestive heart failure or LVEF < 50 by echocardiogram or MUGA scan; History of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify