Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hodgkin Disease
Intervention: Filgrastim SD/01 (Drug); Adriamycin (Drug); Bleomycin (Drug); Vinblastine (Drug); DTIC (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Anas Younes, MD, Principal Investigator, Affiliation: UT MD Anderson Cancer Center
Summary
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD
chemotherapy.
Clinical Details
Official title: Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
UT MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
UT MD Anderson Cancer Center website
Starting date: November 2001
Last updated: July 27, 2012
|