Health Trials

CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

ConditionsBlasts 10-19 Percent of Bone Marrow Nucleated CellsBlasts More Than 5 Percent of Bone Marrow Nucleated CellsHigh Risk Chronic Myelomonocytic LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent High Risk Myelodysplastic SyndromeRefractory Chronic Myelomonocytic LeukemiaRefractory High Risk Myelodysplastic Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)

Patients are either not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment

MDS and CMML classified by International Prognostic Scoring System (IPSS) as intermediate-2/high risk with excess blasts > 5%, or with 10-19% bone marrow blasts

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

Disqualifiers

New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50 by echocardiogram or multigated acquisition (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

Uncontrolled infection not adequately responding to appropriate antibiotics

Female patients who are pregnant or lactating

Trial design

Treatments tested in this trial

  • Liposome-encapsulated Daunorubicin-Cytarabine

Treatment groups

38 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov