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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 is ongoing, but not recruiting participants.
First Received: June 2, 2000   Last Updated: May 9, 2009   History of Changes
Sponsor: Robert H. Lurie Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005787
  Purpose

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
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 I

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Study Start Date: February 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 17 to 65

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • Cardiac ejection fraction normal

Pulmonary:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005787

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067725, NU-99Z1, NCI-G00-1734
Study First Received: June 2, 2000
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00005787     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neutropenia
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:
Flt3 ligand protein
Epoetin Alfa
Radiation-Protective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Hematinics
Hematologic Diseases
Physiological Effects of Drugs
Hematologic Agents
Adjuvants, Immunologic
Agranulocytosis
Leukocyte Disorders
Protective Agents
Pharmacologic Actions
Neutropenia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Leukopenia
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009