Hodgkin Disease
Conditions
Keywords
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
Brief summary
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.
Interventions
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy | Following ABVD chemotherapy course |
Countries
United States
Outcome results
None listed