Clinical trial NCT02096042 (phase 1/phase 2, status: terminated)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: brentuximab vedotin, 5-azacytidine
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, NC1=NC(=O)N(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Reason stopped: 
    slow accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed AML, other than acute promyelocytic
             leukemia, as defined by the 2008 World Health Organization (WHO) criteria that is
             relapsed or refractory to standard chemotherapy. Note: Newly-diagnosed AML patients
             who are 60 years or older and are not candidates for or have refused standard
             chemotherapy are also eligible for this trial.

          2. AML blasts must express CD30 (>/=10% expression as assessed by flow-cytometry or 2+
             expression by immunohistochemistry) (whenever possible CD30 expression will be
             assessed by both methods)

          3. Age 18 years or older

          4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of </=3

          5. The following baseline laboratory data: Serum bilirubin </=1.5 x upper limit of normal
             (ULN) or </= 3 x ULN for patients with Gilbert's disease; Serum creatinine </=1.5 x
             ULN AND creatinine clearance >30 ml/min; Alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) </=3 x ULN

          6. Females of childbearing potential must have a negative serum or urine beta human
             chorionic gonadotrophin (beta-hCG) pregnancy test result within 14 days prior to the
             first dose of brentuximab vedotin and must agree to use an effective contraception
             method during the study and for 30 days following the last dose of study drug. Females
             of non- childbearing potential are those who are postmenopausal greater than 1 year or
             who have had a bilateral tubal ligation or hysterectomy.

          7. Males who have partners of childbearing potential must agree to use an effective
             contraceptive method during the study and for 30 days following the last dose of study
             drug

          8. Patients or their legally authorized representative must provide written informed
             consent.

        Exclusion Criteria:

          1. History of another primary invasive malignancy that has not been definitively treated
             or in remission for at least 2 years. Patients with non-melanoma skin cancers or with
             carcinomas in situ are eligible regardless of the time from diagnosis (including
             concomitant diagnoses).

          2. Documented history of a cerebral vascular event (stroke or transient ischemic attack),
             unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
             Heart Association Class III-IV within 6 months prior to their first dose of
             brentuximab vedotin

          3. Evidence of active cerebral/meningeal disease. Patients may have history of central
             nervous system (CNS) leukemic involvement if definitively treated with prior therapy
             and no evidence of active disease at the time of registration.

          4. Previous treatment with any anti-CD30 directed therapy

          5. Patients with previous allogeneic stem cell transplant (SCT) if they meet either of
             the following criteria: <100 days from allogeneic SCT, Acute or chronic
             graft-versus-host disease (GvHD), or Receiving immunosuppressive therapy as treatment
             for or prophylaxis against GvHD within the last 7 days

          6. Patients with uncontrolled active infections (viral, bacterial, and fungal) are not
             eligible.

          7. Known to be positive for hepatitis B by surface antigen expression

          8. Known to have active hepatitis C infection (positive by polymerase chain reaction or
             on antiviral therapy for hepatitis C within the last 6 months)

          9. Preexisting grade >/=2 peripheral neuropathy

         10. Patients with uncontrolled diabetes mellitus

         11. Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational
             agents.

         12. Chemotherapy (except hydroxyurea or emergent use of single-agent cytarabine for
             cytoreduction), radiotherapy, biologics, and/or other treatment with immunotherapy
             that is not completed 2 weeks prior to first dose of study drug, unless progressive
             disease is documented. NOTE: Hydroxyurea will be allowed during the first cycle of
             treatment

         13. Females who are pregnant or lactating

         14. Known hypersensitivity to any excipient contained in the drug formulation of
             brentuximab vedotin

         15. History of progressive multifocal leukoencephalopathy (PML)