Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
NCT ID: NCT00004232
Last Updated: 2012-06-01
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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COMPLETED
PHASE1
INTERVENTIONAL
1999-10-31
2002-10-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.
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Detailed Description
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* Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation.
* Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population.
OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0.
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover.
Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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filgrastim
cyclosporine
methylprednisolone
prednisone
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS:
Age:
* 10 to 65
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No known sensitivity to E. coli derivatives
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
10 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Richard K. Burt, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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NU-96H4
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1660
Identifier Type: -
Identifier Source: secondary_id
NU FDA96H4
Identifier Type: -
Identifier Source: org_study_id
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