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.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00005787
First received: June 2, 2000
Last updated: May 31, 2012
Last verified: May 2012
  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 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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00005787     History of Changes
Other Study ID Numbers: NU 99Z1, NU-99Z1, NCI-G00-1734
Study First Received: June 2, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 24, 2014