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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| 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: | 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 |
| Study Completion Date: | January 2002 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | Jane N. Winter, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Jane Winter, MD, 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: | July 1, 2011 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Lymphoma Lymphoma, Non-Hodgkin Neutropenia 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 |