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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 3

Conditions: Hodgkin Disease

Treatments: Drug: Filgrastim SD/01; Drug: Vinblastine; Drug: DTIC; Drug: Adriamycin; Drug: Bleomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00038558

ID01-087

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Filgrastim + ABVD Chemotherapy

Experimental group

Treatment:

Drug: Bleomycin

Drug: Adriamycin

Drug: DTIC

Drug: Vinblastine

Drug: Filgrastim SD/01