NCT00038558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

May 31, 2002

Last Update Submit

October 30, 2018

Conditions

Hodgkin Disease

Keywords

Hodgkin's lymphomaDacarbazineDTICDTIC-DomeVinblastineVelbanBleomycin sulfateBlenoxaneBLMDoxorubicin HydrochlorideAdriamycinFilgrastimG-CSFNeupogenPegfilgrastimgranulocyte colony-stimulating factor

Outcome Measures

Primary Outcomes (1)

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

    Following ABVD chemotherapy course

Study Arms (1)

Filgrastim + ABVD Chemotherapy

EXPERIMENTAL
Drug: Filgrastim SD/01Drug: AdriamycinDrug: BleomycinDrug: VinblastineDrug: DTIC

Interventions

Filgrastim SD/01DRUG
Also known as: G-CSF, Neupogen
Filgrastim + ABVD Chemotherapy
AdriamycinDRUG
Also known as: Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF
Filgrastim + ABVD Chemotherapy
BleomycinDRUG
Also known as: Bleomycin sulfate, Blenoxane, BLM
Filgrastim + ABVD Chemotherapy
VinblastineDRUG
Also known as: Velban
Filgrastim + ABVD Chemotherapy
DTICDRUG
Also known as: DTIC-Dome, Dacarbazine
Filgrastim + ABVD Chemotherapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Interventions

pegfilgrastimGranulocyte Colony-Stimulating FactorFilgrastimDoxorubicinBleomycinVinblastineDacarbazine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesGlycopeptidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTriazenesImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Anas Younes, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2002

First Posted

June 3, 2002

Study Start

November 1, 2001

Primary Completion

February 1, 2004

Study Completion

March 1, 2005

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

US(1)