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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


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


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.



- 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.


- HIV positive.

- Pregnant women and those of child bearing age who are not using adequate


- 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

Page last updated: August 23, 2015

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