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

Primary Purpose

Hodgkin Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Filgrastim SD/01
Adriamycin
Bleomycin
Vinblastine
DTIC
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Disease focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Filgrastim + ABVD Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 31, 2002
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00038558
Brief Title
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Official Title
Prophylactic Use of Filgrastim SD/01 In Patients With Hodgkin's Disease Receiving ABVD Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgrastim + ABVD Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Filgrastim SD/01
Other Intervention Name(s)
G-CSF, Neupogen
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Other Intervention Name(s)
Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Other Intervention Name(s)
Bleomycin sulfate, Blenoxane, BLM
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Other Intervention Name(s)
Velban
Intervention Type
Drug
Intervention Name(s)
DTIC
Other Intervention Name(s)
DTIC-Dome, Dacarbazine
Primary Outcome Measure Information:
Title
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy
Time Frame
Following ABVD chemotherapy course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

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