Trial Information
Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
Outcome Time Frame:
Following ABVD chemotherapy course
Safety Issue:
No
Principal Investigator
Anas Younes, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
ID01-087
NCT ID:
NCT00038558
Start Date:
November 2001
Completion Date:
March 2005
Related Keywords:
- Hodgkin Disease
- Hodgkin's lymphoma
- Dacarbazine
- DTIC
- DTIC-Dome
- Vinblastine
- Velban
- Bleomycin sulfate
- Blenoxane
- BLM
- Doxorubicin Hydrochloride
- Adriamycin
- Filgrastim
- G-CSF
- Neupogen
- Pegfilgrastim
- granulocyte colony-stimulating factor
- Hodgkin Disease
Name | Location |
UT MD Anderson Cancer Center |
Houston, Texas 77030 |