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

This study has been terminated.
(Per PI due to poor/inadequate accrual.)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University Identifier:
First received: June 2, 2000
Last updated: May 31, 2012
Last verified: May 2012

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 Intervention Phase
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

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Enrollment: 3
Study Start Date: September 1999
Study Completion Date: January 2002
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   17 Years to 65 Years   (Child, 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
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Please refer to this study by its identifier: NCT00005787

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)
Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Northwestern University Identifier: NCT00005787     History of Changes
Other Study ID Numbers: NU 99Z1
Study First Received: June 2, 2000
Last Updated: May 31, 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:
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 processed this record on April 28, 2017