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

NCT ID: NCT00038558

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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Conditions

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Hodgkin Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Filgrastim + ABVD Chemotherapy

Group Type EXPERIMENTAL

Filgrastim SD/01

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

Interventions

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Filgrastim SD/01

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Bleomycin

Intervention Type DRUG

Vinblastine

Intervention Type DRUG

DTIC

Intervention Type DRUG

Other Intervention Names

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G-CSF Neupogen Doxorubicin Hydrochloride Adriamycin PFS Adriamycin RDF Bleomycin sulfate Blenoxane BLM Velban DTIC-Dome Dacarbazine

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anas Younes, MD

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

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UT MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

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ID01-087

Identifier Type: -

Identifier Source: org_study_id

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