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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038558
First Posted: June 3, 2002
Last Update Posted: July 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
May 31, 2002
June 3, 2002
July 31, 2012
November 2001
February 2004   (Final data collection date for primary outcome measure)
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy [ Time Frame: Following ABVD chemotherapy course ]
Not Provided
Complete list of historical versions of study NCT00038558 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hodgkin Disease
  • Drug: Filgrastim SD/01
    Other Names:
    • G-CSF
    • Neupogen
  • Drug: Adriamycin
    Other Names:
    • Doxorubicin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
  • Drug: Bleomycin
    Other Names:
    • Bleomycin sulfate
    • Blenoxane
    • BLM
  • Drug: Vinblastine
    Other Name: Velban
  • Drug: DTIC
    Other Names:
    • DTIC-Dome
    • Dacarbazine
Experimental: Filgrastim + ABVD Chemotherapy
Interventions:
  • Drug: Filgrastim SD/01
  • Drug: Adriamycin
  • Drug: Bleomycin
  • Drug: Vinblastine
  • Drug: DTIC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2005
February 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00038558
ID01-087
Yes
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Anas Younes, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP