Clinical Trial: Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults With Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality
Brief 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.
Detailed Summary:
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 4 cycles of induction/re-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/RE-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 4 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 4 courses in the absence of disease progression or unacceptable toxicity.
ARM II: (closed to accrual effective 4/21/14) INDUCTION/RE-INDUCTION:
Sponsor: Fred Hutchinson Cancer Research Center
Current Primary Outcome:
- Response (CR or CRp) rate categorized according to criteria recommended by International Working Groups [ Time Frame: Up to 1 month after completion of study treatment ]Responses from patients who achieve CR or CRp will further be categorized based on the presence or absence of minimal residual disease, as assessed by multiparameter flow cytometry.
- TRM rate [ Time Frame: Up to day 28 ]
Original Primary Outcome:
- CR rate [ Time Frame: Up to 1 month after completion of study treatment ]
- TRM rate [ Time Frame: Up to day 28 ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fred Hutchinson Cancer Research Center
Dates:
Date Received: March 1, 2013
Date Started: April 2013
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017