Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
NCT ID: NCT00038558
Last Updated: 2018-10-31
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
PHASE3
25 participants
INTERVENTIONAL
2001-11-30
2005-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Filgrastim + ABVD Chemotherapy
Filgrastim SD/01
Adriamycin
Bleomycin
Vinblastine
DTIC
Interventions
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Filgrastim SD/01
Adriamycin
Bleomycin
Vinblastine
DTIC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven diagnosis of Hodgkin's disease of any type.
* Bidimensionally measurable disease.
* Signed informed consent.
* Age \>/= 16 yrs.
* Adequate bone marrow reserve (ANC\>1000/uL, Platelet \>100,000/uL.
* LVEF\>/=50% by MUGA scan or echocardiogram.
* Serum creatinine \<2mg/dL; serum bilirubin\<2mg/dL.
EXCLUSION:
* HIV positive.
* Pregnant women and those of child bearing age who are not using adequate contraception.
* Prior chemotherapy.
* Severe pulmonary disease including COPD and asthma.
* History of prior sensitivity to E.coli derived products.
16 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anas Younes, MD
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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ID01-087
Identifier Type: -
Identifier Source: org_study_id
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