Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): autologous hematopoietic stem cell transplantation; leukapheresis
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients undergo autologous stem cell transplantation; Stem cells collected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: 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