Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy - Tabular View

Tracking Information
First Received Date ^ICMJE	May 31, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	November 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Official Title ^ICMJE
Brief Summary	For patients with Hodgkin's lymphoma receiving ABVD chemotherapy.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Condition ^ICMJE	Hodgkin Disease
Intervention ^ICMJE	Drug: Filgrastim SD/01 Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	25
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	INCLUSION: Previously untreated Hodgkin's disease patients who are scheduled to receive standard ABVD chemo. 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.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038558
Responsible Party
Study ID Numbers ^ICMJE	ID01-087
Study Sponsor ^ICMJE	M.D. Anderson Cancer Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	M.D. Anderson Cancer Center
Verification Date	June 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP