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Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005787
Recruitment Status : Terminated (Per PI due to poor/inadequate accrual.)
First Posted : January 27, 2003
Last Update Posted : June 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Treating the peripheral stem cells in the laboratory may improve the effectiveness of the transplant.

PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in patients who have relapsed or refractory non-Hodgkin's lymphoma and who will be treated with high-dose chemotherapy.

Condition or disease Intervention/treatment Phase
Lymphoma Neutropenia Biological: epoetin alfa Biological: filgrastim Biological: recombinant flt3 ligand Biological: recombinant interleukin-3 Biological: sargramostim Procedure: in vitro-treated peripheral blood stem cell transplantation Phase 1

Detailed Description:


  • Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma.
  • Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy.
  • Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo.
  • Determine the relationships between length of culture, immunophenotype, and clinical outcome.
  • Determine the required numbers of white blood cell precursors for clinical efficacy.
  • Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period.

OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.

Patients are followed monthly for 1 year.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Primary Purpose: Supportive Care
Official Title: Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy
Study Start Date : September 1999
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven relapsed or refractory non-Hodgkin's lymphoma
  • Scheduled to undergo high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan) with autologous peripheral blood mononuclear cell transplantation
  • No metastatic disease involving the bone marrow



  • 17 to 65

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • No active hepatitis B or C
  • Bilirubin less than 2.5 times normal*
  • SGOT or SGPT less than 2.5 times normal*
  • Alkaline phosphatase less than 2.5 times normal NOTE: * Unless Gilbert's syndrome present


  • Creatinine clearance greater than 50 mL/min


  • Cardiac ejection fraction normal


  • DLCO at least 50% predicted
  • FEV_1 and FVC at least 75% predicted


  • HIV negative
  • Not pregnant
  • Negative pregnancy test
  • No non-neoplastic disease that would preclude intensive chemotherapy


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • No prior external beam radiotherapy to more than 25% of the active bone marrow


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005787

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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
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Responsible Party: Northwestern University Identifier: NCT00005787    
Other Study ID Numbers: NU 99Z1
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Northwestern University:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukocyte Disorders
Hematologic Diseases
Epoetin Alfa
Flt3 ligand protein
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents