RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy used to kill tumor cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells. PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy, peripheral stem cell transplantation, and donor white blood cell infusions in treating older patients who have acute myeloid leukemia.

Condition	Treatment or Intervention	Phase
adult acute differentiated monocytic leukemia (M5b) adult acute myeloblastic leukemia without maturation (M1) adult acute poorly differentiated monocytic leukemia (M5a) adult acute erythroleukemia (M6) adult acute myeloid leukemia in remission adult acute myelomonocytic leukemia (M4) adult acute myeloblastic leukemia with maturation (M2) adult acute megakaryocytic leukemia (M7)	Drug: allogeneic lymphocytes	Phase II

Further Study Details: 

OBJECTIVES: I. Determine whether mixed or full donor chimerism can be safely established in older patients with acute myeloid leukemia (AML) treated with nonmyeloablative conditioning comprised of low dose total body irradiation, followed by allogeneic peripheral blood stem cell transplantation, followed by unrelated donor lymphocyte infusion (DLI). II. Determine whether mixed chimerism can be safely converted to full donor chimerism in patients treated with DLI. III. Determine the potential efficacy of this regimen in AML patients who are in first remission.

PROTOCOL OUTLINE: Conditioning: Patients undergo low dose total body irradiation followed by infusion of allogeneic peripheral blood stem cells (PBSC) on day 0. Donor lymphocyte infusions: Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on day 95 after PBSC transplantation. Eligible patients with mixed chimerism and no graft versus host disease (GVHD) receive the first donor lymphocyte infusion (DLI) on the same day that donor lymphocytes are collected. Patients who continue to have mixed chimerism and no GVHD receive the second DLI at a higher dose level on day 65 after the first DLI. Patients are followed weekly until day 90, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  55 Years   -   74 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Acute myeloid leukemia (AML) (de novo or secondary, FAB M1, M2 and M4-7); Must be within 6 months of diagnosis; Achieved a chemotherapy induced first complete remission (CR); Received 1 or more courses of consolidation chemotherapy OR AML in second or greater CR
• Patients with a documented first or subsequent CR may proceed to transplantation if: No morphologic diagnosis of AML or myelodysplastic syndrome; Absolute neutrophil count greater than 1,000/mm3 and platelet count greater than 50,000/mm3 after any consolidation chemotherapy
• Availability of an HLA identical related peripheral blood stem cell donor; No syngeneic donor
• No active CNS leukemia

--Prior/Concurrent Therapy--

• See Disease Characteristics

--Patient Characteristics--

• Age: Over 55 to under 75
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: See Disease Characteristics
• Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); ALT and AST less than 4 times ULN
• Renal: Creatinine clearance at least 50 mL/min
• Cardiovascular: Cardiac ejection fraction at least 40%; No poorly controlled hypertension
• Pulmonary: No severe defects in pulmonary function testing; No requirement for supplementary continuous oxygen

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States

Study chairs or principal investigators

Brenda Sandmaier,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000067776; FHCRC-1406.00; NCI-G00-1778
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005801
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08