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OpenTrials
Completed

NCT Number: NCT00038558

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

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

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Key information

Conditions

Hodgkin Disease Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgrastim SD/01

Drug

Other names: G-CSF, Neupogen

Adriamycin

Drug

Other names: Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF

Bleomycin

Drug

Other names: Bleomycin sulfate, Blenoxane, BLM

Vinblastine

Drug

Other names: Velban

DTIC

Drug

Other names: DTIC-Dome, Dacarbazine

Primary outcomes

  1. Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy

    Time frame: Following ABVD chemotherapy course

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2001
Primary completion
2004
Study completion
2005
First posted
Jun 3, 2002
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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