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NCT00038558 Clinical Trial

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

Hodgkin Disease Clinical Trial

Official title:
Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038558
Other study ID # ID01-087
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2001
Est. completion date March 2005

Study information
Verified date October 2018
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date March 2005
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Filgrastim SD/01

• Adriamycin

• Bleomycin

• Vinblastine

• DTIC

Locations
Country Name City State
United States UT MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy Following ABVD chemotherapy course
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