G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders
NCT ID: NCT00253552
Last Updated: 2012-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2004-05-31
2006-05-31
Brief Summary
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PURPOSE: This clinical trial is studying how well a G-CSF-treated donor bone marrow transplant works in treating patients with hematologic cancer or noncancer.
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Detailed Description
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Primary
* Determine whether granulocyte engraftment can be achieved by day 30 in patients with hematologic disorders undergoing HLA-matched, related-donor, allogeneic bone marrow transplantation using filgrastim (G-CSF)-primed bone marrow.
* Determine the incidence of grade II or greater acute graft-versus-host disease (GVHD) in patients treated with this regimen and post-transplantation immunosuppression with cyclosporine and methotrexate.
Secondary
* Determine whether platelet and red blood cell engraftment can be achieved in patients treated with this regimen.
* Determine the incidence of limited and extensive chronic GVHD in patients treated with this regimen.
* Determine the event-free survival of patients treated with this regimen.
* Determine the post-transplant immune reconstitution in patients treated with this regimen.
OUTLINE: This is a pilot study.
* Mobilization: Donors receive filgrastim (G-CSF) subcutaneously (SC) daily on days -3 to -1 followed by bone marrow collection.
* Conditioning regimen: Patients receive 1 of the following conditioning regimens according to their primary disease:
* Total-body irradiation and high-dose chemotherapy comprising etoposide and cyclophosphamide
* High-dose chemotherapy comprising busulfan and cyclophosphamide
* Bone marrow transplantation: Patients receive G-CSF-primed allogeneic bone marrow on day 0. Patients then receive G-CSF SC beginning on day 5.
* Graft-versus-host disease prophylaxis: Patients receive cyclosporine beginning on day -1 and methotrexate on days 1, 3, and 6.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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filgrastim
busulfan
cyclophosphamide
cyclosporine
etoposide
methotrexate
allogeneic bone marrow transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hematologic malignancy or nonmalignancy
* Candidate for matched, related-donor, allogeneic bone marrow transplantation
* Availability of an HLA-matched (6/6) related donor
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2 OR
* Karnofsky or Lansky 70-100%
Life expectancy
* At least 12 weeks
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No significant functional deficit of any major organ
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior stem cell transplantation
24 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Eneida Nemecek, MD
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
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Other Identifiers
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OHSU-HEM-04007-L
Identifier Type: OTHER
Identifier Source: secondary_id
OHSU-1381
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000445188
Identifier Type: -
Identifier Source: org_study_id
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