Clinical trial NCT03672851 (phase 1, status: terminated)
Conditions: acute leukemia, acute leukemia in relapse, acute myeloid leukemia, relapsed or refractory acute leukemia
ICD codes: C91.01, C91.02, C92.01, C92.02, C92.41, C92.42, C92.51, C92.A1, C92.A2, C92.61, C92.62, C92.A0, C92.60
Drugs: anti-cd123 car-t treatment
SMILES: COC1=CC=CC=C1OC1=C(NS(=O)(=O)C2=CC=C(C=C2)C(C)(C)C)N=C(N=C1OCCO)C1=NC=CC=N1
Reason stopped: 
    adverse effect
  
Eligibility criteria:

        Inclusion Criteria:

          1. Research patients enrolled are those patients with relapsed or refractory CD123+ acute
             leukemia (Acute Myeloid Leukemia/ acute lymphoblastic leukemia );

          2. Relapsed: is defined as patients that had a first complete remission (CR) before
             developing recurrent disease (increased bone marrow blasts);

          3. Refractory: is defined as patients that have not achieved a first CR after 2 cycles of
             induction chemotherapy; for patients with leukemia evolving from myelodysplastic
             syndrome, they should have completed at least one cycle of induction chemotherapy;

          4. Research participants must have bone marrow and/or peripheral blood samples available
             for confirmation of diagnosis; CD123 positivity must be confirmed by either flow
             cytometry or immunohistochemistry within 90 days of study entry; cytogenetics, flow
             cytometry, and molecular studies (such as FMS-like tyrosine kinase-3 [FLT-3] status)
             will be obtained as per standard practice;

          5. Karnofsky performance status score >= 70;

          6. Women of child-bearing potential and men must agree to use adequate contraception
             prior to study entry and for six months following duration of study participation;
             should a woman become pregnant or suspect that she is pregnant while participating on
             the trial, she should inform her treating physician immediately;

          7. Calculated creatinine clearance (absolute value) of >= 50 mL/minute or creatinine <
             2.0 mg/dl or < 2 times upper limit of normal for the research participant's age group;

          8. Serum bilirubin =< 3.0 mg/dL;

          9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 times the
             institutional upper limits of normal;

         10. Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan
             (MUGA) >= 50%;

         11. Diffusion capacity of carbon monoxide (DLCO) or forced expiratory volume in one second
             (FEV1) > 45% predicted;

         12. Research participants' last dose of prior chemotherapy or radiation must be >= 2 weeks
             before leukapheresis;

         13. If a research participant has undergone prior allogeneic stem cell transplant, he/she
             must be off all immunosuppressants for graft versus host disease (GVHD) for at least 2
             weeks before undergoing leukapheresis;

         14. Negative serum or urine pregnancy test;

         15. All research participants must have the ability to understand and willingness to sign
             a written informed consent or age appropriate assent for pediatric patients.

        Exclusion Criteria:

          1. Acute Promyelocytic Leukemia, t(15,17) (q22;q12);

          2. Pregnant and lactating women;

          3. Research participants who have tested human immunodeficiency virus (HIV) positive, or
             have active hepatitis B or C infection, or poorly controlled infection;

          4. History of allergic reactions attributed to compounds of similar chemical or
             biological composition to cetuximab

          5. Dependence on corticosteroids (5mg/day prednisone more than 2 weeks);

          6. A known hypersensitivity to any of the test materials or related compounds;

          7. Presence of active and clinically relevant Central Nervous System (CNS) disorder;

          8. Undergone prior allogeneic stem cell transplant, GVHD occurred within 6 months,
             requiring immunosuppressive therapy;

          9. Active autoimmune disease, such as psoriasis and rheumatoid arthritis;

         10. Other situations the clinicians think not eligible for participation in the research.