Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
NCT ID: NCT00003961
Last Updated: 2014-04-17
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
PHASE2
INTERVENTIONAL
1999-04-30
2007-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of sargramostim after bone marrow transplantation in treating patients who have myelodysplastic syndrome.
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Detailed Description
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* Determine the effect of sargramostim (GM-CSF) on the progression-free 1-year survival of patients with myelodysplastic syndrome who have undergone T-cell-depleted CD34+ augmented allogeneic bone marrow transplantation.
OUTLINE: All patients receive elutriated, CD34+ stem cell augmented donor bone marrow according to another protocol on day 0.
Patients receive sargramostim (GM-CSF) subcutaneously on days 5-60.
Patients are followed on days 120, 180, 360 and periodically thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 3-4 years.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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sargramostim
Eligibility Criteria
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Inclusion Criteria
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 prior acute allergic reactions to sargramostim (GM-CSF)
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Principal Investigators
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B. Douglas Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Other Identifiers
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JHOC-J9852
Identifier Type: -
Identifier Source: secondary_id
JHOC-98071505
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1544
Identifier Type: -
Identifier Source: secondary_id
CDR0000067160, J9852
Identifier Type: -
Identifier Source: org_study_id
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