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

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Bleomycin; Dacarbazine; Doxorubicin; Lenograstim; Liposomal doxorubicin; Vinblastine

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.