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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038558
Recruitment Status : Completed
First Posted : June 3, 2002
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment Phase
Hodgkin Disease Drug: Filgrastim SD/01 Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Study Start Date : November 2001
Actual Primary Completion Date : February 2004
Actual Study Completion Date : March 2005

Arm Intervention/treatment
Experimental: Filgrastim + ABVD Chemotherapy Drug: Filgrastim SD/01
Other Names:
  • G-CSF
  • Neupogen

Drug: Adriamycin
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF

Drug: Bleomycin
Other Names:
  • Bleomycin sulfate
  • Blenoxane
  • BLM

Drug: Vinblastine
Other Name: Velban

Drug: DTIC
Other Names:
  • DTIC-Dome
  • Dacarbazine

Primary Outcome Measures :
  1. Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy [ Time Frame: Following ABVD chemotherapy course ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 contraception.
  • Prior chemotherapy.
  • Severe pulmonary disease including COPD and asthma.
  • History of prior sensitivity to E.coli derived products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038558

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Anas Younes, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038558    
Other Study ID Numbers: ID01-087
First Posted: June 3, 2002    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by M.D. Anderson Cancer Center:
Hodgkin's lymphoma
Bleomycin sulfate
Doxorubicin Hydrochloride
granulocyte colony-stimulating factor
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators