Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (CPX-351) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes

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PRIMARY OBJECTIVE: I. To compare the rate of overall complete response (CR)/complete response with incomplete hematologic recovery (CRi) with liposome-encapsulated daunorubicin-cytarabine (CPX-351) + pomalidomide versus CPX-351 alone in newly diagnosed scute myeloid leukemia (AML) with preexisting m...

PRIMARY OBJECTIVE: I. To compare the rate of overall complete response (CR)/complete response with incomplete hematologic recovery (CRi) with liposome-encapsulated daunorubicin-cytarabine (CPX-351) + pomalidomide versus CPX-351 alone in newly diagnosed scute myeloid leukemia (AML) with preexisting myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myeloproliferative neoplasm (MPN); therapy-related AML (t-AML); or AML with myelodysplasia-related changes (MRC) based on cytogenetics or morphologic dysplasia. SECONDARY OBJECTIVES: I. To evaluate and compare toxicities (including treatment-related mortality) of CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. II. To detect and compare the presence of minimal residual disease (MRD) by flow cytometry in those who achieve CR/CRi with CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. III. To compare median event-free survival (EFS) of CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. IV. To compare median overall survival (OS) of CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. V. To compare median and 2-year disease-free survival (DFS) after CR/CRi with CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. VI. To compare rates of allogeneic stem cell transplant (SCT) after CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. EXPLORATORY OBJECTIVES: I. To assess for molecular biomarkers, Aiolos expression, and immune correlates of response with CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. II. To assess for differences in MRD by molecular based platforms in CPX-351 + pomalidomide versus CPX-351 alone in newly diagnosed AML with preexisting MDS, CMML or MPN, t-AML, or AML with MRC based on cytogenetics or morphologic dysplasia. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 and then pomalidomide orally (PO) once daily (QD) beginning between days 21-30 for 21 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. ARM B: INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

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