Prophylactic Use of Filgrastim SD/01 in Patients With Hod... | NCT00038558

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

NCT00038558

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Oct 31, 2018Actual

Enrollment

25Actual

Phase

Phase 3

Conditions

Hodgkin Disease

Interventions

Filgrastim SD/01
Adriamycin
Bleomycin
Vinblastine
DTIC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2001

Primary Completion Date

Feb 2004Actual

Completion Date

Mar 2005Actual

First Submitted Date

May 31, 2002

First Submission Date that Met QC Criteria

May 31, 2002

First Posted Date

Jun 3, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2018

Last Update Posted Date

Oct 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Filgrastim + ABVD Chemotherapy	Experimental		Drug: Filgrastim SD/01 Drug: Adriamycin Drug: Bleomycin Drug: Vinblastine Drug: DTIC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Filgrastim SD/01	Drug		Filgrastim + ABVD Chemotherapy	G-CSF Neupogen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients with Response to Prophylactic Filgrastim SD/01Chemotherapy		Following ABVD chemotherapy course

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anas Younes, MD	UT MD Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT MD Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
UT MD Anderson Cancer Center website	View source

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C455861	pegfilgrastim
D016179	Granulocyte Colony-Stimulating Factor
D000069585	Filgrastim
D004317	Doxorubicin
D001761	Bleomycin
D014747	Vinblastine
D003606	Dacarbazine

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided