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VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00274794
First received: January 10, 2006
Last updated: March 28, 2011
Last verified: March 2011

January 10, 2006
March 28, 2011
February 2000
May 2006   (final data collection date for primary outcome measure)
  • Correlate CD34+ cell yields with the addition of rituximab [ Time Frame: At least two weeks prior to transplant ] [ Designated as safety issue: No ]
  • Acute toxicity of rituximab, etoposide, and filgrastim (G-CSF) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00274794 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL
A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies

RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkin's lymphoma.
  • Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients.

OUTLINE: This is a randomized study.

  • Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms.

    • Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 17 and continuing until approximately day 25. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
    • Arm II: Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11. Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected. After stem cell collection is completed, patients proceed to the preparative regimen.
  • Preparative regimen: Patients receive oral busulfan once daily on days -8 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on days -3 and -2.
  • Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo autologous PBSCT on day 0. Beginning on day 5, patients receive G-CSF SC or IV once daily until blood counts recover.

After completion study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: filgrastim
    10mcg/kg/d subcutaneously, beginning 48 hours after completion of Etoposide
  • Biological: rituximab
    375 mg/m2, IV, Once per week for 3 weeks.
  • Rituxan + Etoposide + G-CSF
    Interventions:
    • Biological: filgrastim
    • Biological: rituximab
  • Etoposide + G-CSF
    Intervention: Biological: filgrastim
Copelan E, Pohlman B, Rybicki L, Kalaycio M, Sobecks R, Andresen S, Dean R, Koo A, Chan J, Sweetenham J, Bolwell B. A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin's lymphoma. Bone Marrow Transplant. 2009 Jan;43(2):101-5. Epub 2008 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
May 2006
May 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria:

    • Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL)
    • Patients with B-cell NHL in first remission and who have significant risk for later relapse
    • Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation

PATIENT CHARACTERISTICS:

  • Life expectancy at least 2 months
  • Cardiac ejection fraction ≥ 45%
  • DLCO ≥ 45%
  • Creatinine < 2.0 mg/dL
  • Bilirubin < 2.0 mg/dL
  • AST < 2 times normal
  • Platelet count ≥ 50,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Absolute lymphocyte count ≤ 10,000/mm^3
  • HIV negative
  • No severe medical or psychiatric illnesses
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • More than 8 weeks since prior rituximab
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00274794
CASE-CCF-3600, P30CA043703, CASE-CCF-3600, CASE-CCF-0467
No
Brian Bolwell, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
The Cleveland Clinic
National Cancer Institute (NCI)
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute
The Cleveland Clinic
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP