Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults With Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality
PRIMARY OBJECTIVES:
I. Estimate whether the 32 units/m^2 or the 64 units/m^2 or both dose levels of CPX-351
(liposomal cytarabine-daunorubicin CPX-351) are likely to improve treatment-related
mortality (TRM) rate while keeping the complete remission (CR) rate constant in patients
with untreated high-risk myelodysplastic syndrome (MDS) or non-acute promyelocytic leukemia
(APL) acute myeloid leukemia (AML) at high risk of TRM.
SECONDARY OBJECTIVES:
I. Describe the CR/CR with incomplete platelet count recovery (CRp) rate after up to 2
cycles of induction therapy.
II. Describe the event-free survival, disease-free survival, and overall survival of
patients who achieve CR/CRp.
III. Estimate the frequency and severity of regimen-associated toxicities.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I:
INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351
intravenously (IV) over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for
2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving
CR or CRp continue on to consolidation.
CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over
90 minutes on days 1 and 3. Treatment repeats every 40 days for 2 courses in the absence of
disease progression or unacceptable toxicity.
ARM II:
INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90
minutes on days 1, 3, and 5. Treatment repeats every 40 days for 2 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to
consolidation.
CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV
over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 2 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
CR rate
Up to 1 month after completion of study treatment
No
Roland Walter
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
2642.00
NCT01804101
April 2013
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |