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Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01238211
First received: November 9, 2010
Last updated: July 21, 2014
Last verified: February 2014

November 9, 2010
July 21, 2014
December 2010
July 2013   (final data collection date for primary outcome measure)
30 Day Survival Rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Percentage of participants who were alive 30 days after starting induction treatment.
  • 30-day survival rate during induction therapy [ Designated as safety issue: No ]
  • Absence of pleural or pericardial effusion [ Designated as safety issue: No ]
  • Absence of liver toxicity that exceeds grade 2 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01238211 on ClinicalTrials.gov Archive Site
  • Event-free Survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

    Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,

    Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts).

  • Complete Response Rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

    Percentage of participants who achieve a CR.

    CR is defined in the above outcome measure.

  • Cumulative Incidence of Relapse [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Cumulative Incidence of Death [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Disease-free Survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The median DFS with 95% CI was estimated using the Kaplan-Meier method.
  • Overall Survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as time from registration to death. The median OS with 95% CI was estimated using the Kaplan-Meier method.
  • Rate of early/hypoplastic death [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Complete response rate [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Cumulative incidence of relapse [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
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)

This phase II trial is studying the side effects and how well giving combination chemotherapy together with dasatinib works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with dasatinib may kill more cancer cells.

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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 regimens.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
  • Drug: daunorubicin hydrochloride
    Given IV
    Other Names:
    • Cerubidin
    • Cerubidine
    • daunomycin hydrochloride
    • daunorubicin
    • RP-13057
  • Drug: cytarabine
    Given IV
    Other Names:
    • ARA-C
    • arabinofuranosylcytosine
    • arabinosylcytosine
    • Cytosar-U
    • cytosine arabinoside
  • Drug: dasatinib
    Given PO
    Other Names:
    • BMS-354825
    • Sprycel
Experimental: Treatment (daunorubicin hydrochloride, cytarabine, dasatinib)

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 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.

Interventions:
  • Drug: daunorubicin hydrochloride
  • Drug: cytarabine
  • Drug: dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
61
Not Provided
July 2013   (final data collection date for primary outcome measure)

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 vasectomy)
    • 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 agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01238211
NCI-2011-02615, NCI-2011-02615, CALGB-10801, CDR0000688434, CALGB 10801, CALGB-10801, P30CA014236, U10CA031946
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Guido Marcucci Cancer and Leukemia Group B
National Cancer Institute (NCI)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP