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Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib (NSC #732517, IND #73969) and Continuation Therapy With Dasatinib Alone in Newly Diagnosed Patients With Core Binding Factor Acute Myeloid Leukemia (AML)

Phase 2
18 Years
Not Enrolling
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, 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), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

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Trial Information

Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib (NSC #732517, IND #73969) and Continuation Therapy With Dasatinib Alone in Newly Diagnosed Patients With Core Binding Factor Acute Myeloid Leukemia (AML)


I. To assess the safety and tolerability of dasatinib with intensive induction therapy
(daunorubicin hydrochloride and cytarabine), consolidation chemotherapy (high-dose
cytarabine), and as single agent in maintenance therapy in patients with newly diagnosed
core-binding factor acute myeloid leukemia (AML).


I. To assess clinical outcomes such as event-free survival (EFS), complete response rate
(CR), cumulative incidence of relapse (CIR), cumulative incidence of death (CID),
disease-free survival (DFS), and overall survival (OS) of patients treated with these

II. To describe the frequency and severity of adverse events of patients treated on this
study during induction, consolidation, and continuation therapy.

III. To describe the interaction of pretreatment disease and patient characteristics
including morphology, cytogenetics, immunophenotype, molecular genetic features, white blood
cell count and hemogram, and performance status on clinical outcomes.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY (course 1): Patients receive daunorubicin hydrochloride IV on days 1-3,
cytarabine IV continuously over 168 hours on days 1-7, and dasatinib orally (PO) once daily
on days 8-21. Patients with responsive disease on day 21 undergo consolidation therapy, and
patients with non-responsive disease on day 21 (bone marrow cellularity ≥ 20 % and leukemia
blasts ≥ 5%) receive a second course of induction therapy.

INDUCTION THERAPY (course 2): Patients receive daunorubicin hydrochloride IV on days 1-3,
cytarabine IV continuously over 120 hours on days 1-5, and dasatinib PO once a day on days
6-19. Patients achieving complete response receive consolidation therapy.

CONSOLIDATION THERAPY: Patients receive high-dose cytarabine IV over 3 hours on days 1, 3,
and 5, and dasatinib PO once daily on days 6-26. Treatment repeats every 28 days for 4
courses in the absence of disease progression or unacceptable toxicity. Patients in complete
remission receive continuation therapy.

CONTINUATION THERAPY: Patients receive dasatinib PO on days 1-28. Treatment repeats every 28
days for 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 2 months for 2 years,
every 3 months for 2 years, and then every year for a up to 10 years.

Inclusion Criteria:

- Newly diagnosed acute myeloid leukemia (AML)

- Molecular diagnosis of core-binding factor (CBF) AML by RT-PCR positive for any
of the following:

- RUNX1-RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22) or a
variant form

- CBFB-MYH11 fusion transcript resulting from inv(16)(p13.1q22)
ort(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the
diagnosis of CBFAML based on the WHO classification)

- AML with a history of antecedent myelodysplasia (MDS) allowed

- Patients who have developed therapy-related myeloid neoplasm (t-MN) after prior
radiotherapy or chemotherapy for another cancer or disorder allowed

- Must be registered on CALGB-8461 and CALGB-20202 protocols

- May also be registered on CALGB-9665

- Bilirubin < 2.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must agree to use two acceptable methods of birth control before,
during, and for ≥ 12 weeks after treatment is complete:

- One highly effective method (e.g., IUD, hormonal, tubal ligation, or partner's

- One additional effective method (e.g., latex condom, diaphragm, or cervical cap)

- Left ventricular ejection fraction >= lower limit of institutional normal by MUGA or
ECHO scan

- No myocardial infarction within 6 months

- No ventricular tachyarrhythmia within 6 months

- No major conduction abnormality (unless a cardiac pacemaker is present)

- No patients with congenital QT syndrome or non-congenital QTc prolongation (≥ 480
msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of
other medications prior to start of treatment

- No concurrent proton pump inhibitors

- No prior chemotherapy for leukemia or myelodysplasia except the following:

- Emergency leukapheresis

- Emergency treatment for hyperleukocytosis with hydroxyurea

- Cranial radiotherapy for CNS leukostasis (one dose only)

- Growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival rate during induction therapy

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Guido Marcucci

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • 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)
  • Secondary Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



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