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Pegfilgrastim Compared With Filgrastim To Increase Peripheral Stem Cells Before Autologous Stem Cell Transplantation in Treating Patients With Lymphoma - Article


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Adult Hodgkin's Lymphoma


Clinical Trial: Pegfilgrastim Compared With Filgrastim To Increase Peripheral Stem Cells Before Autologous Stem Cell Transplantation in Treating Patients With Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Colony-stimulating factors such as filgrastim and pegfilgrastim may increase the number of peripheral stem cells that can be collected during leukapheresis. Autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of pegfilgrastim with that of filgrastim in increasing the number of peripheral stem cells in patients who are undergoing autologous stem cell transplantation for Hodgkin's lymphoma or non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult Hodgkin's lymphoma
adult non-Hodgkin's lymphoma
Cutaneous T-Cell Lymphoma
 Drug: filgrastim
 Drug: pegfilgrastim
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Peripheral Blood Progenitor Cell Mobilization By Pegfilgrastim or Filgrastim (G-CSF) for Autologous Transplantation in Patients With Hodgkin's or Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to amount of prior chemotherapy or radiotherapy (heavily pretreated vs non-heavily pretreated). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive lower dose pegfilgrastim subcutaneously (SC) on day 1 and placebo SC on days 1-9.
  • Arm II: Patients receive higher dose pegfilgrastim SC on day 1 and placebo SC on days 2-9.
  • Arm III: Patients receive filgrastim (G-CSF) SC on days 1-9.
  • Leukapheresis: Patients undergo leukapheresis daily, beginning on day 5 until the desired yield of CD34+ cells is obtained or a maximum of 5 leukaphereses is reached.
  • Conditioning: Patients receive a myeloablative chemotherapy regimen as per institutional practice.
  • Transplantation of PBPC: Approximately 1-3 days after completion of the conditioning regimen, patients undergo reinfusion of autologous PBPC. Patients receive G-CSF SC beginning on day of reinfusion and continuing until blood counts recover. Patients are followed at 60 and 100 days.

PROJECTED ACCRUAL: A total of 90 patients (30 patients per treatment arm) will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 80,000/mm^3
  • No hemolytic anemia or hemoglobinopathy

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • No hepatic cirrhosis

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • More than 6 months since prior coronary angioplasty
  • No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mm Hg)
  • No unstable angina
  • No New York Heart Association class III or IV congestive heart failure
  • No uncontrolled atrial or ventricular cardiac arrhythmias

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • No prior bone marrow or PBPC transplantation
  • More than 1 week since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • WBC must be less than 15,000/mm^3 if growth factor support was administered concurrently with prior chemotherapy
  • No other concurrent G-CSF or GM-CSF
  • No other concurrent myeloid stimulating factors
  • No concurrent radioimmunotherapy

Chemotherapy

  • More than 3 weeks since prior myelosuppressive chemotherapy

Endocrine therapy

  • More than 14 days since prior corticosteroids
  • No concurrent corticosteroids

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other


Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Christos E. Emmanouilides, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000301567; UCLA-0212059; AMGEN-2002112
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060229
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 11, 2008



Page Updated: September 6, 2005
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