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Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma

This study is currently recruiting participants.
Study NCT00566228.   Last updated on October 22, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title † Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
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
Brief Summary

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.
Detailed Description

OBJECTIVES:

Primary

  • Determine the therapeutic effect of instrument-driven lymphocyte enrichment of the autograft absolute lymphocyte count (A-ALC) compared to "standard autograft collection" as determined by progression-free survival post-transplantation.

Secondary

  • Determine the profile of immune effector cells of the "lymphocyte enriched autograft" vs "standard autograft" and peripheral blood after autologous stem cell transplant (ASCT) and their impact on post- ASCT immunological reconstitution and clinical endpoints.
  • Perform quantitative and functional analysis of T, B, NK, and dendritic cells from the apheresis product and peripheral blood samples at multiple timepoints after transplantation.
  • Determine and compare the proportion of patients who are progression-free and alive at 1 and 2 years.
  • Determine the differences in overall survival between the two collection method arms.
  • Evaluate and characterize differences in transplantation outcomes (e.g., time to ALC engraftment, incidence of infection, and the CD34 count) between the two collection method arms.

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).

  • Immunologic autograft engineering: 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).
  • Standard autograft collection: 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.

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.
Study Phase Phase III
Study Type † Interventional
Study Design † Treatment, Randomized, Double-Blind
Primary Outcome Measure † Evaluation and comparison of progression-free survival between the two arms at 1 and 2 years [ Designated as safety issue: No ]
Adverse outcomes after transplantation (e.g., elongation of time to engraftment, issues with ability for patients to engraft, and elevated incidence of infection) [ Designated as safety issue: Yes ]
Secondary Outcome Measure † Evaluation and comparison of the direct proportion of patients who are progression-free at 1 year between the two treatment arms [ Designated as safety issue: No ]
Evaluation and comparison of overall survival between patients [ Designated as safety issue: No ]
Evaluation and comparison of the proportion of patients who are progression-free at 2 years [ Designated as safety issue: No ]
Evaluation and comparison of the time to absolute lymphocyte count engraftment between the two arms [ Designated as safety issue: No ]
Evaluation and comparison of immunologic recovery within and between the arms by assessing the quantitative and functional immune effector cells (T, B, or NK cells) from the apheresis product [ Designated as safety issue: No ]
Measurement and comparison of tolerability and transplantation success for each of the two arms, specifically, the CD34 count, number of platelet transfusions required, incidence of infections, and incidence of collection reactions [ Designated as safety issue: Yes ]
Condition † Lymphoma
Intervention † Procedure: autologous hematopoietic stem cell transplantation
Procedure: leukapheresis
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 126
Start Date † December 2007
Completion Date
Eligibility Criteria †

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse large cell lymphoma

    • Low-grade non-Hodgkin lymphoma transformed to diffuse large cell lymphoma allowed

  • Candidate for with autologous peripheral blood stem cell transplantation

    • Not requiring bone marrow harvest to collect stem cells
    • No chemotherapy with filgrastim ( G-CSF) or mobilization study drug (i.e., AMD3100) needed for mobilization of stem cells

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Cardiac and pulmonary status sufficient to undergo apheresis and stem cell transplantation
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active uncontrolled infection requiring antibiotic treatment
  • No comorbid condition which, in view of the investigators, renders the patient at high risk from treatment complications
  • Willing to provide all research blood samples as required by the protocol

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior chemotherapy (rituxan is not considered chemotherapy for the purpose of this study)
  • More than 4 weeks since prior experimental therapy
  • No concurrent enrollment on another experimental protocol during the mobilization phase
  • No concurrent participation in any autologous stem cell transplantation study that is not using the standard conditioning regimens for lymphomas
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00566228
Organization ID CDR0000577897
Secondary IDs †† MAYO-MC0681
Study Sponsor † Mayo Clinic
Collaborators †† National Cancer Institute (NCI)
Investigators †
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    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2008
First Received Date † November 30, 2007
Last Updated Date October 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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