• Toxicity by NCI CTCAE criteria [ Designated as safety issue: Yes ]
  

• Effects of anti-CD45 on normal hematopoiesis and on complement levels [ Designated as safety issue: No ]
  
• Effects of anti-CD45 on leukemic blast cells [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• To evaluate the toxicity and the anti-tumor activity of anti-CD45 monoclonal antibody in patients with relapsed or resistant leukemia or other hematologic malignancy undergoing allogeneic stem cell transplantation.

Secondary

• To describe the effects of anti-CD45 on normal hematopoiesis and on complement levels.
• To describe the effects of anti-CD45 on leukemic blast cells.

OUTLINE:

• Preparative regimen: Patients receive treatment based on their relationship to the stem cell donor (related or unrelated).

  • HLA-identical or 5/6 matched related donors: Patients receive anti-CD45 monoclonal antibody IV on days -5 to -2, cytarabine IV twice daily on days -7 to -5, cyclophosphamide IV on days -7 and -6. Patients also undergo total body irradiation twice daily on days -4 to -1.
  • HLA-identical or 5/6 matched unrelated donors: Patients receive anti-CD45 monoclonal antibody, cytarabine, and cyclophosphamide and undergo total-body irradiation therapy as above. Patients also receive alemtuzumab IV on days -8 to -6.
• Allogeneic stem cell transplantation: All patients undergo peripheral blood or bone marrow stem cell infusion on day 0.
• Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV beginning on day -2 and continuing as per the treating physician.

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of advanced leukemia or other hematologic malignancy, including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia (CML), or myelodysplastic disease

  • Advanced features include any of the following:

    • Induction failure, prolonged induction beyond 6 weeks
    • Incomplete response to salvage therapy
    • CML in blast crisis or acute leukemia in chemotherapy resistant relapse
    • Secondary leukemia or secondary myelodysplastic disease
• CD45 present on leukemic blasts at a level of > 95% as documented by flow cytometry
• HLA identical sibling donor or 5/6 matched related donor OR fully matched or 5/6 matched unrelated donor available
• No T-cell lymphoblastic lymphoma

PATIENT CHARACTERISTICS:

• Lansky performance status (PS) 70-100%% or Karnofsky PS 70-100%
• Life expectancy > 6 weeks (not limited by diseases other than leukemia)
• No symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
• No liver disease that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
• Creatinine ≤ 2 times upper limit of normal
• No known allergy to rat serum products
• No severe infection that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
• No severe personality disorder or mental illness
• No documented HIV positivity
• Not pregnant or lactating

PRIOR CONCURRENT THERAPY:

• Not specified