Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission
Condition: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasm Metastasis; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Myelodysplastic Syndromes
Intervention: nonmyeloablative allogeneic hematopoietic stem cell transplantation; fludarabine phosphate; total-body irradiation; cyclosporine; mycophenolate mofetil; peripheral blood stem cell transplantation
Intervention description: Undergo nonmyeloablative allogeneic PBSC transplant; Given IV; Undergo TBI; Given PO; Given PO; Undergo nonmyeloablative allogeneic PBSC transplant
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Fludarabine; Fludarabine phosphate; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well reduced intensity donor peripheral blood stem cell
      (PBSC) transplant works in treating patients with de novo or secondary acute myeloid leukemia
      (AML) in remission. Giving low doses of chemotherapy, such as fludarabine phosphate, and
      total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer
      cells. It may also stop the patient's immune system from rejecting the donor's stem cells.
      The donated stem cells may replace the patient's immune cells and help destroy any remaining
      cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can
      also make an immune response against the body's normal cells. Giving cyclosporine and
      mycophenolate mofetil after the transplant may stop this from happening
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with de novo AML (French-American-British [FAB] MO-M2, M4-M7) or secondary
             AML who achieve CR1 after induction chemotherapy and one or two cycles of
             consolidation chemotherapy

          -  Transplant conditioning must occur within 6 months of diagnosis

          -  Patient enrollment must be approved by the Fred Hutchinson Cancer Research Center
             (FHCRC) principal investigator (PI) or the PI's designee

          -  DONOR: Related donor who is genotypically or phenotypically identical

          -  DONOR: Age >= 12 years

          -  DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

          -  DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
             central venous catheter (femoral, subclavian)

        Exclusion Criteria:

          -  AML FAB M3

          -  AML involvement of the central nervous system (CNS) as defined by a positive cytospin
             of cerebral spinal fluid at the time of enrollment

          -  Presence of circulating leukemic blasts (in the peripheral blood) detected by standard
             pathology

          -  Human immunodeficiency virus (HIV) seropositivity

          -  Fungal infections with radiographic progression after receipt of amphotericin B or
             active triazole for greater than one month

          -  Diffusion capacity of carbon monoxide (DLCO) corrected < 40%

          -  Total lung capacity (TLC) < 40%

          -  Forced expiratory volume in one second (FEV1) < 40% or requiring supplementary oxygen

          -  The FHCRC principal investigator of the study must approve enrollment of all patients
             with pulmonary nodules

          -  Cardiac ejection fraction < 40%

          -  Patients with clinical or laboratory evidence of liver disease would be evaluated for
             the cause of liver disease, its clinical severity in terms of liver function, bridging
             fibrosis, and the degree of portal hypertension; patients will be excluded if they are
             found to have fulminant liver failure, cirrhosis of the liver with evidence of portal
             hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding
             esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic
             dysfunction evinced by prolongation of the prothrombin time, ascites related to portal
             hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral
             hepatitis with total serum bilirubin > 3mg/dL, or symptomatic biliary disease

          -  Karnofsky Performance Score < 70

          -  Fertile men or women unwilling to use contraceptive techniques during and for 12
             months following treatment

          -  Females who are pregnant or breastfeeding

          -  No intensive chemotherapy can be given within three weeks (or the interval in which a
             cycle of standard chemotherapy would be administered in a non-transplant setting)
             prior to initiating the nonmyeloablative transplant conditioning

          -  Patients with active non-hematologic malignancies (except non-melanoma skin cancers)

          -  Patients with a history of non-hematologic malignancies (except non-melanoma skin
             cancers) currently in a complete remission, who are less than 5 years from the time of
             complete remission, and have a > 20% risk of disease recurrence

          -  Patients with active bacterial or fungal infections unresponsive to medical therapy

          -  DONOR: Identical twin

          -  DONOR: Pregnancy

          -  DONOR: HIV seropositivity

          -  DONOR: Inability to achieve adequate venous access

          -  DONOR: Known allergy to G-CSF

          -  DONOR: Current serious systemic illness