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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00566228
First received: November 30, 2007
Last updated: April 7, 2014
Last verified: April 2014

November 30, 2007
April 7, 2014
December 2007
December 2014   (final data collection date for 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 ]
  • Evaluation and comparison of progression-free survival between the two arms at 1 and 2 years
  • Adverse outcomes after transplant (e.g., elongation of time to engraftment, issues with ability for patients to engraft, and elevated incidence of infection)
Complete list of historical versions of study NCT00566228 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluation and comparison of the direct proportion of patients who are progression-free at 1 year between the two treatment arms
  • Evaluation and comparison of overall survival between patients
  • Evaluation and comparison of the proportion of patients who are progression-free at 2 years
  • Evaluation and comparison of the time to absolute lymphocyte count (ALC) engraftment between the two arms
  • 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
  • Measurement and comparison of tolerability and transplant success for each of the two arms, specifically, the CD34 count, number of platelet transfusions required, incidence of infections, and incidence of collection reactions
Not Provided
Not Provided
 
Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Lymphoma
  • Procedure: autologous hematopoietic stem cell transplantation
    Patients undergo autologous stem cell transplantation
  • Procedure: leukapheresis
    Stem cells collected
  • Experimental: 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).
    Interventions:
    • Procedure: autologous hematopoietic stem cell transplantation
    • Procedure: leukapheresis
  • Active Comparator: 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.
    Interventions:
    • Procedure: autologous hematopoietic stem cell transplantation
    • Procedure: leukapheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
158
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566228
MC0681, P30CA015083, MC0681, 07-000789
Yes
Luis F. Porrata, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Luis F. Porrata, MD Mayo Clinic
Mayo Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP