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Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults With Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality


N/A
18 Years
N/A
Open (Enrolling)
Both
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), de Novo Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

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.


Inclusion Criteria:



- Diagnosis of untreated "high-risk" MDS (>= 10% blasts) or AML other than 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 (< 10% blasts); all treatments for MDS should be discontinued prior
to start of CPX-351 treatment

- TRM score >= 13.1 as calculated with simplified model

- Bilirubin < 2.0 mg/mL x upper limit of normal

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 4.0 x upper limit
of normal

- Left ventricular ejection fraction (LVEF) >= 40%, assessed within 28 days prior to
registration, e.g. by multi gated acquisition scan (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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR rate

Outcome Time Frame:

Up to 1 month after completion of study treatment

Safety Issue:

No

Principal Investigator

Roland Walter

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

2642.00

NCT ID:

NCT01804101

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • de Novo Myelodysplastic Syndromes
  • Secondary Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Chronic

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109