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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038558
First received: May 31, 2002
Last updated: July 27, 2012
Last verified: July 2012

May 31, 2002
July 27, 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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038558
ID01-087
Yes
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