IPA Targeted Adoptive Immunotherapy vs Adult Haplo-identical Cell Infusion During Induction of High Risk Leukemia

Inclusion Criteria:

1. Patients must be 18 years of age or older
2. Patients with a confirmed diagnosis of AML or MDS, according to World Health Organization (WHO) classification (excluding acute promyelocytic leukaemia) with recurrent or refractory disease as defined below.

   1. For AML:

      1. Primary induction failure (PIF) after ≥ 2 cycles of chemotherapy.
      2. First relapse.
      3. Relapse refractory to salvage chemotherapy
      4. Second or subsequent relapse.
   2. For MDS, either refractory anemia with excess blasts (RAEB) I or RAEB II who failed at least one chemotherapy regimen including either cytarabine or a hypomethylating agent.
3. Patients must have Karnofsky Performance score of ≥70
4. Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
5. Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form

Exclusion Criteria:

1. Persistent clinically significant toxicities from previous chemotherapy
2. Known positive status for human immunodeficiency virus (HIV)
3. Pregnant and nursing patients
4. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
5. Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
6. Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any New York Heart Association (NYHA) grade 3 or 4.
7. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities