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Clinical Trial 19639

Cancer Type:
Interventions:BMS-936558 (Nivolumab); Cytarabine (Cytosine Arabinoside); Midostaurin; Nivolumab; azacitidine (5-azacitidine); decitabine (5-aza-2'-deoxycytidine)

Study Type: Treatment
Phase of Study: Phase II/III

  • Kendra Sweet

Call 813-745-6100
or 1-800-679-0775

Study Title

A Randomized Phase II/III Trial of Novel Therapeutics versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) Or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older


The purpose of this study is to compare any good and bad effects of using different new treatment options to one of the current standard treatment options given for patients with AML or MDS who cannot tolerate or do not want to get intensive chemotherapy.


1.1 Primary Objectives: a. Phase II Component: To select, based on overall survival, any or all of the Novel Therapeutic regimens for further testing against azacitidine in patients age 60 and older with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome with excessive blasts-2 (MDS-EB-2). b. Phase III Component: To compare overall survival of the "Novel Therapeutic" regimens selected in the Phase II portion of the trial to azacitidine in these patient populations. 1.2 Secondary Objectives: a. To estimate the frequency and severity of toxicities of the regimens in these patient populations. b. To estimate response rates, event-free survival, and relapse-free survival for these regimens in these patient populations. 1.3 Additional Objectives: a. To investigate associations between cytogenetic and molecular abnormalities (including FLT3) and outcomes for each of the regimens in these patient populations. b. To bank specimens for future correlative studies.

Inclusion Criteria

  • Men and women age 60 years or older
  • Participants must be suspected to have previously untreated acute myelogenous leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2)
  • Must not be known to have AML in the central nervous system (CNS)
  • Must have specimens submitted for FLT3 testing for randomization stratification
  • Must be offered participation in specimen banking; with patient consent, pretreatment specimens must be collected and submitted via the SWOG Specimen Tracking System
  • Participants must be able to swallow oral medications without crushing or chewing
  • Prior malignancy is allowed providing it does not require concurrent therapy, Exception: active hormonal therapy is allowed
  • Women must not be pregnant or nursing. All participants must follow contraception guidelines in the study documentation.
  • Prior treatment with hydroxyurea is permitted; prior all-trans retinoic acid (ATRA) for suspected APL and prior intrathecal therapy are permitted, but must plan to be discontinued prior to initiating protocol therapy; patients with signs/symptoms of hyperleukocytosis or white blood cells (WBC) >= 50,000/mcL can be treated with leukapheresis prior to randomization (registration to Step 2)
  • May have received non-intensive therapy for antecedent hematologic disorders, including lenalidomide; patients may have received prior chemotherapy for prior cancers; these therapies must be discontinued at least 5 days prior to randomization (registration to Step 2)
  • Patients who are transfusion-dependent and patients receiving growth factor support are eligible; participants must discontinue growth factor support prior to initiation of protocol therapy
  • The following tests must be performed within 14 days prior to randomization (registration to Step 2) to establish baseline values: Performance status; Complete blood count (CBC)/differential/platelets; Creatinine clearance (Cockcroft-Gault); Total bilirubin; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT); Lactate dehydrogenase (LDH); Albumin; Glucose; Fibrinogen; Electrocardiogram (ECG).

  • Exclusion Criteria

  • Patients who have received prior therapy with midostaurin, any anti-PD-1 or anti-PD-L1 therapy, any deoxyribonucleic acid (DNA)-methyltransferase inhibitor (including hypomethylating agents such as azacitidine, decitabine, or other investigational agent that acts by inhibiting DNA or ribonucleic acid [RNA] methylation) for any condition, or prior intensive cytotoxic therapy for myelodysplastic syndrome (MDS), are not eligible
  • Additional criteria may apply