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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Evaluation and comparison of progression-free survival between the two arms at 1 and 2 years

Safety Issue:

No

Principal Investigator

Luis F. Porrata, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

MC0681

NCT ID:

NCT00566228

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Mayo ClinicRochester, Minnesota  55905