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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00038558
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
40
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
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 :
Nov 1, 2001
Actual Primary Completion Date :
Feb 1, 2004
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

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 Names:
  • Velban

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy [Following ABVD chemotherapy course]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UT MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Anas Younes, MD, UT MD Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00038558
    Other Study ID Numbers:
    • ID01-087
    First Posted:
    Jun 3, 2002
    Last Update Posted:
    Oct 31, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by M.D. Anderson Cancer Center
    Hodgkin's lymphoma
    Dacarbazine
    DTIC
    DTIC-Dome
    Vinblastine
    Velban
    Bleomycin sulfate
    Blenoxane
    BLM
    Doxorubicin Hydrochloride
    Adriamycin
    Filgrastim
    G-CSF
    Neupogen
    Pegfilgrastim
    granulocyte colony-stimulating factor
    Additional relevant MeSH terms:
    Hodgkin Disease
    Doxorubicin
    Liposomal doxorubicin
    Bleomycin
    Dacarbazine
    Vinblastine

    Study Results

    No Results Posted as of Oct 31, 2018