OBJECTIVES:

• Determine whether the use of sargramostim (GM-CSF) after T-cell depleted, CD34-positive cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in patients with chronic myelogenous leukemia.

OUTLINE: Patients receive myeloablation with busulfan and cyclophosphamide on an approved protocol. Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody. T-cell depleted, CD34-positive cell-supplemented bone marrow is infused on day 0. Patients receive high-dose sargramostim (GM-CSF) subcutaneously (SC) beginning on day 5 and continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60.

Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation without GM-CSF is considered in case of primary or secondary engraftment failure.

Patients are followed every month for 3 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 6-10 years.

DISEASE CHARACTERISTICS:

• Diagnosis of chronic myelogenous leukemia (CML) documented by cytogenetic and molecular analyses at Johns Hopkins

  • Philadelphia chromosome (Ph)-positive or -negative CML

    • Ph-negative CML allowed with presence of either:

      • BCR-ABL rearrangement (on molecular, fluorescent in situ hybridization, or polymerase chain reaction analyses)
      • p210 protein

• One of the following:

  • Patient age 18 to 65
  • Disease duration longer than 3 years
  • Accelerated phase CML

• Accelerated phase diagnosis based on any of the following:

  • More than 10% to less than 30% blasts in blood or bone marrow
  • No hematologic response to prior conventional therapy (hydroxyurea or interferon)
  • Extramedullary disease (e.g., progressive splenomegaly or lymphadenopathy)
  • Basophilia greater than 10% in blood or bone marrow
  • Other cytogenetic abnormalities in addition to a single Ph chromosome
  • Second chronic phase

• Failure on interferon suggested of patients over age 18 with chronic phase CML, with failure defined as:

  • No detectable Ph-negative metaphases in marrow after 6 months
  • No progressive increase in Ph-negative metaphases in marrow after 6-12 months
  • Less than 50% Ph-negative metaphases after 1 year
  • No complete cytogenetic remission after 2 years
  • Intolerance to interferon therapy
• No blast crisis CML, chronic myelomonocytic leukemia, or juvenile CML

• The following conditions are allowed:

  • Leukocyte count abnormalities
  • Fibrosis
  • Anemia
  • Fever or bone pain
  • Thrombocytopenia
  • Bone marrow reticulin

• Availability of an HLA-identical sibling donor

  • At least 3 years of age (priority given to donors over age 10)
  • Priority given to CMV-negative donor if patient CMV-negative
  • No medical or psychiatric condition that precludes transplant procedure

PATIENT CHARACTERISTICS:

Age

• 18 to 65

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Not specified

Renal

• Not specified

Other

• No history of intolerance to sargramostim (GM-CSF)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified