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



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

For Condition: Hodgkin Disease
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: For patients with Hodgkin's lymphoma receiving ABVD chemotherapy.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 25

Location and Contact Information:

MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:  id01-087; 
Study Start Date: November 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038558

Other Hodgkin Disease Studies:
1. Pegfilgrastim PBPC Mobilization Study

2. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes

3. Safety and efficacy of an investigational drug in the prevention of thrombocytopenia in recurrent or refractory non-Burkitt's, non-Hodgkin's lymphoma (NHL) or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine and Cisplatin) chemotherapy

4. Gene marked cytotoxic T-cells for patients with relapsed Hodgkin's Lymphoma.

5. Giving Gene Marked Epstein Barr Virus (EBV) Specific T-Cells to Patients Receiving a Bone Marrow Transplant (BMT) for Relapsed EBV-Positive Hodgkin Disease

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