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Trial record 67 of 883 for:    "Reticulum Cell Sarcoma"

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

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ClinicalTrials.gov Identifier: NCT00566228
Recruitment Status : Completed
First Posted : December 3, 2007
Results First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Lymphoma Procedure: autologous hematopoietic stem cell transplantation Procedure: leukapheresis Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2007
Actual Primary Completion Date : January 15, 2015
Actual Study Completion Date : January 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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).
Procedure: autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation

Procedure: leukapheresis
Stem cells collected

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.
Procedure: autologous hematopoietic stem cell transplantation
Patients undergo autologous stem cell transplantation

Procedure: leukapheresis
Stem cells collected




Primary Outcome Measures :
  1. Median Progression-free Survival [ Time Frame: Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment. ]
    Progression free survival (PFS) was defined as the time from the date of infusion to disease progression, relapse, or death from any cause. Patients alive without disease progression or relapse were censored at their last disease evaluation or at their secondary primary cancer diagnosis, whichever occurred first. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the sum of the products of diameters (SPD) of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm). A log rank test was used to assess whether PFS differed with respect to apheresis collection method.


Secondary Outcome Measures :
  1. Progression-free Survival Rate at 1 Year [ Time Frame: Date of infusion to disease progression, relapse, or death from any cause, up to one year ]
    Progression-free survival rate (percentage) at one year is defined as 100 times the number of patients who have not progressed, relapsed and/or died divided by the total number of evaluable patients in each arm. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the SPD of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm).

  2. Progression-free Survival Rate at 2 Years [ Time Frame: Date of infusion to disease progression, relapse, or death from any cause, up to two years ]
    Progression-free survival rate (percentage) at two years is defined as 100 times the number of patients who have not progressed, relapsed and/or died divided by the total number of evaluable patients in each arm. Criteria for Relapsed Disease: Appearance of any new lesion or increase by ≥50% in the size of previously involved sites, ≥50% increase in greatest diameter of any previously identified node >1.0 cm in its short axis or in the SPD of more than one node. Criteria for Progressive Disease: ≥50% increase from nadir in the SPD of any previously identified abnormal node or ALC for partial remissions or non-responders, Appearance of any new lesion (≥ 2x2 cm).

  3. One-year Overall Survival Rate [ Time Frame: date of infusion to death from any cause, up to one year ]
    Overall survival (OS) was defined at the time from infusion to death from any cause. The one-year OS rate is defined as the percentage of patients who are still alive after one year. A log rank test was used to assess whether OS differed with respect to apheresis collection method.

  4. Median Time to Absolute Lymphocyte Count Engraftment [ Time Frame: Up to 30 days after autologous peripheral hematopoietic stem cell transplantation ]
    The time to absolute lymphocyte count (ALC) engraftment will be evaluated and compared between the two arms, where time to ALC engraftment is defined as the time from transplant to the time they achieve ALC > 500.

  5. Median Number of CD34 Cells/kg Infused [ Time Frame: 5 to 7 days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater ]
    Five (5) to seven (7) days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greater, stem cell collection began. Apheresis collections were to be performed daily. At least 2 x 10^6 CD34 cells/kg were to be collected. Additional collections were at the discretion of the transplantation team. The median number of CD34 cells/kg infused are reported for each arm below.


Other Outcome Measures:
  1. 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 [ Time Frame: Baseline ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566228


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Study Chair: Luis F. Porrata, MD Mayo Clinic

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00566228     History of Changes
Other Study ID Numbers: MC0681
P30CA015083 ( U.S. NIH Grant/Contract )
MC0681 ( Other Identifier: Mayo Clinic Cancer Center )
07-000789 ( Other Identifier: Mayo Clinic IRB )
First Posted: December 3, 2007    Key Record Dates
Results First Posted: July 9, 2018
Last Update Posted: July 9, 2018
Last Verified: June 2018
Keywords provided by Mayo Clinic:
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin