Donor Cellular Therapy After Cytarabine in Treating Patients With Intermediate-Risk Acute Myeloid Leukemia in Remission

Inclusion Criteria:

PATIENT INCLUSION CRITERIA:

Acute myeloid leukemia-intermediate risk as defined by standard World Health Organization (WHO) criteria for AML (at least 20% blasts in the peripheral blood or bone marrow) at the time of initial diagnosis

Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with French-American-British (FAB) classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration and biopsy performed within 14 days prior to administration of 1st dose of remission induction chemotherapy
Intermediate risk based on National Comprehensive Cancer Network (NCCN)
In CR or complete remission with incomplete blood count recovery (CRi) after 1-2 induction chemotherapy documented by a bone marrow examination done within 2 weeks of starting cytarabine in this protocol
Must have achieved CR/CRi with less than 2 induction regimens that contain cytarabine and anthracycline
No 10/10 matched sibling donor available or not financially eligible for allogeneic stem cell transplantation
Must be within 3 months from the last induction regimen at the time of starting cytarabine chemotherapy in this protocol
Patient has at least one medically fit first- or second-degree family member expected to be human leukocyte antigen (HLA) mismatched at 2-9/10 loci; in addition, the prospective donor is willing to voluntarily donate hematopoietic stem cells and sign consent forms
Absolute neutrophil count (ANC) > 1500, unless due to direct bone marrow involvement of disease
Platelets > 75,000, unless due to direct bone marrow involvement of disease
Hemoglobin > 8.0 gm/dL, transfusion allowed
Serum creatinine < 2.0 x the upper limits of institutional normal (ULN)
Total bilirubin < 1.5 x the upper limits of institutional normal
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x the upper limits of institutional normal (=< 5 x ULN for patients with suspected liver involvement of leukemia)
Cardiac left ventricular ejection fraction (LVEF) > 45%
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, and estimated survival of at least 3 months
Patients must be able to understand and agree to sign an Institutional Review Board (IRB)-approved informed consent form
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study, and for two months after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
DONOR INCLUSION CRITERIA:
Donor screening; all donors will meet the standard blood donor criteria established by the participating local blood center, American Association of Blood Banks (AABB)
Donors will be selected from among the subject's relatives, adult children preferred
Infectious disease testing will be done per Hemacare policy and AAAB guidelines
Donor and intended recipient red cell type and compatibility will be determined
Donors will be pre-selected on the basis of HLA haploidentity
If patient is cytomegalovirus (CMV)-negative, donors who are CMV-negative will be preferred; CMV serology of the donor will be tested prior to the allogeneic cell donation; donations from CMV-positive donors to CMV-negative recipients will be given if no CMV negative donor is available, and CMV surveillance and pre-emptive treatment given as per guidelines below

Exclusion Criteria:

PATIENT EXCLUSION CRITERIA:
Acute promyelocytic leukemia
High risk AML (see NCCN risk criteria)
Low risk AML (see NCCN risk criteria)
Fludarabine based therapy within 6 months of enrollment
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Who are pregnant and/or lactating
Who have had non-biopsy surgery in the last 10 days
Who have active central nervous system (CNS) disease; patients with previously treated leptomeningeal disease without evidence of remaining leukemia cells by spinal fluid will be eligible
Patients with known active autoimmune disorder
Patients known to be have active hepatitis B or C; (hepatitis B positive patients are allowed if they are on appropriate antiviral agents such as lamivudine)
Patients concurrently taking the following drugs are excluded: mycophenolate, cyclosporine, prednisone > 20 mg/day, or immunosuppressive agents
Researchers think that any life-threatening illness, condition or organ system dysfunction can damage the safety of subjects
Failure to demonstrate adequate compliance with medical therapy and follow-up
DONOR EXCLUSION CRITERIA:
Personal or family history of severe sickle cell disease or variant (unless donor has tested negative); testing for the presence of hemoglobin S is not required
Positive infectious disease test as dictated by blood collection center's standard operating procedure (SOP)
Current uncontrolled hypertension
Pregnant or breast-feeding
Currently taking lithium therapy
History of autoimmune disease