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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00566228 |
RATIONALE: It is not yet known which method of stem cell collection is best for patients undergoing an autologous stem cell transplant.
PURPOSE: This randomized phase III trial is comparing two different methods of collecting stem cells in patients undergoing stem cell transplant for diffuse large cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Procedure: autologous hematopoietic stem cell transplantation Procedure: leukapheresis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind |
Official Title: | Randomized, Double-Blind Phase III Clinical Trial Comparing Outcomes of Immunologic Autograft Engineering Versus Standard Autograft Collection in Patients Undergoing Autologous Stem Cell Transplantation for Lymphoma |
Estimated Enrollment: | 126 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Immunologic autograft engineering: Experimental
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients undergo ASCT IV on the day of apheresis (lymphocyte enriched autograft).
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Procedure: autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation
Procedure: leukapheresis
Stem cells collected
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Standard autograft collection: Active Comparator
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0). Patients undergo ASCT IV on the day of apheresis.
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Procedure: autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation
Procedure: leukapheresis
Stem cells collected
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OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to baseline International Prognostic Factor (≥ 2 factors vs < 2 factors) and PET scan findings prior to transplantation (positive vs negative). Patients receive filgrastim (G-CSF) alone or G-CSF and sargramostim (GM-CSF) daily for stem cell mobilization. Once the peripheral CD34-positive cell count reaches ≥ 10/μL, patients undergo stem cell collection. Patients are then randomized to 1 of 2 treatment arms for standard autologous stem cell transplantation (ASCT).
Patients undergo blood sample collection periodically for immunological studies. Samples are analyzed for immunophenotyping of immune cell subsets via multicolor flow cytometry, immunoglobulin reconstitution, and functional T-cell immunity.
After completion of study treatment, patients are followed at day 15 post ASCT and then at 3, 6, 9, and 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of diffuse large cell lymphoma
Candidate for with autologous peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Luis F. Porrata, MD | Mayo Clinic |
Investigator: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | Dennis A. Gastineau, MD | Mayo Clinic |
Investigator: | Jeffrey L. Winters, MD | Mayo Clinic |
Investigator: | Edwin A. Burgstaler, MT, HP(ASCP) | Mayo Clinic |
Investigator: | David J. Inwards, MD | Mayo Clinic |
Investigator: | Stephen M. Ansell, MD, PhD | Mayo Clinic |
Investigator: | Ivana Micallef, MD | Mayo Clinic |
Investigator: | Patrick Johnston, MD, PhD | Mayo Clinic |
Investigator: | R. Katipamula, MD | Mayo Clinic |
Study ID Numbers: | CDR0000577897, MAYO-MC0681 |
Study First Received: | November 30, 2007 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00566228 |
Health Authority: | Unspecified |
noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Recurrence |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |