N/A
Completed N=48
Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia
Source: ClinicalTrials.gov NCT01804101 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Treatment-related Mortality Rate. (TRM) — 6; 2 Participants
Summary
This randomized clinical trial studies liposomal cytarabine-daunorubicin CPX-351 in treating patients with untreated myelodysplastic syndrome or acute myeloid leukemia. Drugs used in chemotherapy, such as liposomal cytarabine-daunorubicin CPX-351, 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Mortality Rate. (TRM) |
6; 2 | — |
| SECONDARY Overall Remission Rate (CR+CRp) |
10; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of untreated "high-risk" MDS (>= 10% blasts) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 World Health Organization (WHO) classification; patients with biphenotypic AML are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available
- Prior hydroxyurea for AML is permitted but should be discontinued prior to start of CPX-351 treatment
- Azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk MDS ( = 13.1 as calculated with simplified model
- Bilirubin = 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality
- Patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) > 100,000/uL can be treated with leukapheresis prior to enrollment
- Provide signed written informed consent
Exclusion Criteria
- Refractory/relapsing blast crisis of chronic myelogenous leukemia (CML)
- Concomitant illness associated with a likely survival of < 1 year
- Active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours
Data sourced from ClinicalTrials.gov (NCT01804101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.