Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Jan 26, 2003

Keywords

ClinConnect Summary

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 conti...

Gender

ALL

Eligibility criteria

• 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