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

Therapuetic Areas:Oncology
Age Range:18 - 120
Start Date:December 2007
End Date:January 15, 2015

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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.



- 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.


- 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

- 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.


- 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


- ECOG performance status 0-1

- Cardiac and pulmonary status sufficient to undergo apheresis and stem cell

- 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


- 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

- No concurrent participation in any autologous stem cell transplantation study that is
not using the standard conditioning regimens for lymphomas
We found this trial at
Rochester, Minnesota 55905
Rochester, MN
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