Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia

Inclusion Criteria:

• This study is open to patients with acute myeloid leukemia (AML) evaluated within 30days of the start of conditioning regimen and in first or second complete remission (CR)

• Karnofsky performance status (KPS) >= 70%

• The effects of radiation on the developing fetus are known to be teratogenic; forthis reason, women of child-bearing potential and men must agree to use adequatecontraception (hormonal or barrier method of birth control or abstinence) prior tostudy entry and for six months following duration of study participation; should awoman become pregnant or suspect that she is pregnant while participating on thetrial, she should inform her treating physician immediately

• Patients with acute myelogenous leukemia (AML) who are in first or second completeremission

• All candidates for this study must have a human leukocyte antigen (HLA) (A, B, C,DR) identical sibling who is willing to donate primed blood stem cells (preferred)or bone marrow, or have a 10/10 allele matched unrelated donor; all ABO blood groupcombinations of the donor/recipient are acceptable since even major ABOcompatibilities can be dealt with by various techniques; (red cell exchange orplasma exchange)

• A cardiac evaluation with an electrocardiogram showing no ischemic changes orabnormal rhythm and an ejection fraction of >= 50% established by multi-gatedacquisition scan (MUGA) or echocardiogram

• Patients must have a serum creatinine of less than or equal to 1.3 mg/dL orcreatinine clearance > 70 ml/min as calculated by the Cockcroft-Gault formula

• A bilirubin of less than or equal to 1.5 mg/dL, excluding patients with Gilbert'sdisease

• Patients should also have a serum glutamic-oxaloacetic transaminase (SGOT) and serumglutamate pyruvate transaminase (SGPT) less than 5 times the upper limit of normal

• Pulmonary function tests including diffusing capacity of the lung for carbonmonoxide (DLCO) will be performed; forced expiratory volume in 1 second (FEV 1) andDLCO should be greater than 50% of predicted normal value

• All subjects must have the ability to understand and the willingness to sign awritten informed consent; signed informed consent form approved by the InstitutionalReview Board (IRB) is required; the patient, family member, and transplant staffphysician (physician, nurse, and social worker) meet at least once prior to startingthe transplant procedure; during this meeting, all pertinent information withrespect to risks and benefits to the donor and recipient will be presented;alternative treatment modalities will be discussed

• The time from the end of last induction, re-induction, or consolidation regimenshould be greater than or equal to 14 days

• Prior therapy with etoposide and cyclophosphamide is allowed

• DONOR: donor evaluation and eligibility will be assessed as per current City of Hopestandard operating procedure (SOP)

Exclusion Criteria:

• Patients should not have any uncontrolled illness including ongoing or active orpoorly controlled infection

• Patients may not be receiving any other investigational agents, or concurrentbiological, chemotherapy, or radiation therapy; maintenance therapy with Food andDrug Administration (FDA)-approved targeted therapies (e.g. tyrosine kinaseinhibitors for Philadelphia chromosome [Ph] positive [+] acute lymphoblasticleukemia [ALL], and FLT inhibitors for FLT3+ patients) will be allowed after day 60disease assessment

• Prior radiation therapy that would exclude the use of TMLI

• Relapsed patients who have undergone autologous or allogeneic hematopoietic stemcell transplantation previously

• Patients with psychological or medical condition that patient's physician deemsunacceptable to proceed to allogeneic hematopoietic stem cell transplantation

• Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or anechocardiogram or MUGA scan showing abnormal wall motion or ejection fraction < 50%

• Patients who have been treated with chemotherapy or radiation for the purpose ofinduction, re-induction or consolidation, within two weeks of planned studyenrollment

• Patients with other active malignancies are ineligible for this study, other thanlocalized malignancies

• Patients that are pregnant or breastfeeding

• Any other condition that would, in the investigator's judgment, contraindicate thepatient's participation in the clinical study due to safety concerns or compliancewith clinical study procedures, including but not limited to,infection/inflammation, intestinal obstruction, unable to swallow medication,social/ psychological issues, etc.

• Subjects, who in the opinion of the investigator, may not be able to comply with thesafety monitoring requirements of the study