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


Phase 3
16 Years
N/A
Not Enrolling
Both
Hodgkin Disease

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Following ABVD chemotherapy course

Safety Issue:

No

Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID01-087

NCT ID:

NCT00038558

Start Date:

November 2001

Completion Date:

March 2005

Related Keywords:

  • Hodgkin Disease
  • 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
  • Hodgkin Disease

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030