GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
18 Years
65 Years
Both
Leukemia
Trial Information
GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
B. Douglas Smith, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000064783
NCT ID:
NCT00002778
Start Date:
February 1995
Completion Date:
July 2010
Related Keywords:
- Leukemia
- relapsing chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- accelerated phase chronic myelogenous leukemia
- Philadelphia chromosome positive chronic myelogenous leukemia
- Philadelphia chromosome negative chronic myelogenous leukemia
- atypical chronic myeloid leukemia
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
