N/A
N=48
Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia
Acute Biphenotypic Leukemia · Acute Myeloid Leukemia · Myelodysplastic Syndrome · Untreated Adult Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01804101 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Treatment-related Mortality Rate. (TRM) — 6; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laboratory Biomarker Analysis (Other); Liposomal Cytarabine-Daunorubicin CPX-351 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Mortality Rate. (TRM) |
6; 2 | — |
| SECONDARY Overall Remission Rate (CR+CRp) |
10; 1 | — |
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.
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.