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Trial record 67 of 882 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Procedure: autologous hematopoietic stem cell transplantation
Procedure: leukapheresis
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Period Title: Overall Study
Started 62 60
Completed 56 55
Not Completed 6 5
Reason Not Completed
Withdrawal by Subject             1             0
Attempt to mobilize stem cells failed             2             2
Unable to collect sufficient CD34 cells             3             2
progressed before infusion could occur             0             1
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection Total
Hide Arm/Group Description Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0). Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
All patients who started the study and did not withdraw consent prior to the start of treatment were included.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 61 participants 60 participants 121 participants
58
(50 to 64)
58
(49 to 64)
58
(50 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
16
  26.2%
20
  33.3%
36
  29.8%
Male
45
  73.8%
40
  66.7%
85
  70.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 61 participants 60 participants 121 participants
61
 100.0%
60
 100.0%
121
 100.0%
1.Primary Outcome
Title Median Progression-free Survival
Hide Description 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.
Time Frame Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description:
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Overall Number of Participants Analyzed 56 55
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median and 95% confidence interval was not reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunologic Autograft Engineering, Standard Autograft Collection
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.690
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.62 to 2.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival Rate at 1 Year
Hide Description 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).
Time Frame Date of infusion to disease progression, relapse, or death from any cause, up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description:
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
73.1
(62.3 to 85.7)
65.4
(53.9 to 79.3)
3.Secondary Outcome
Title Progression-free Survival Rate at 2 Years
Hide Description 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).
Time Frame Date of infusion to disease progression, relapse, or death from any cause, up to two years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description:
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
57.9
(46.1 to 72.7)
65.4
(53.9 to 79.3)
4.Secondary Outcome
Title One-year Overall Survival Rate
Hide Description 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.
Time Frame date of infusion to death from any cause, up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description:
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
91.1
(83.9 to 98.9)
83.6
(74.4 to 94.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunologic Autograft Engineering, Standard Autograft Collection
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Median Time to Absolute Lymphocyte Count Engraftment
Hide Description 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.
Time Frame Up to 30 days after autologous peripheral hematopoietic stem cell transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description:
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Overall Number of Participants Analyzed 56 55
Median (Full Range)
Unit of Measure: days
14
(10 to 30)
14
(10 to 30)
6.Secondary Outcome
Title Median Number of CD34 Cells/kg Infused
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description:
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
Overall Number of Participants Analyzed 56 55
Median (Full Range)
Unit of Measure: x10^6 cells/kg
4.6
(2.0 to 8.2)
5.3
(3.0 to 11.4)
7.Other Pre-specified Outcome
Title 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
Hide Description 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
Outcome Measure Data Not Reported
Time Frame At completion of apheresis collection; Up to 2 years.
Adverse Event Reporting Description CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
 
Arm/Group Title Immunologic Autograft Engineering Standard Autograft Collection
Hide Arm/Group Description Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0). Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
All-Cause Mortality
Immunologic Autograft Engineering Standard Autograft Collection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)      0/57 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Immunologic Autograft Engineering Standard Autograft Collection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/57 (0.00%)      0/57 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immunologic Autograft Engineering Standard Autograft Collection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/57 (38.60%)      17/57 (29.82%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  5/57 (8.77%)  5 4/57 (7.02%)  4
Cardiac disorders     
Atrial fibrillation  1  1/57 (1.75%)  1 0/57 (0.00%)  0
Atrial tachycardia  1  1/57 (1.75%)  1 0/57 (0.00%)  0
General disorders     
Injection site reaction  1  0/57 (0.00%)  0 3/57 (5.26%)  3
Injury, poisoning and procedural complications     
Bruising  1  11/57 (19.30%)  11 9/57 (15.79%)  9
Investigations     
Platelet count decreased  1  6/57 (10.53%)  6 4/57 (7.02%)  4
Nervous system disorders     
Peripheral sensory neuropathy  1  5/57 (8.77%)  5 6/57 (10.53%)  6
1
Term from vocabulary, MedDRA 6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Luis F. Porrata, M.D.
Organization: Mayo Clinic
Phone: 507/284–2511
EMail: Porrata.Luis@mayo.edu
Layout table for additonal information
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 Submitted: November 30, 2007
First Posted: December 3, 2007
Results First Submitted: May 1, 2018
Results First Posted: July 9, 2018
Last Update Posted: July 9, 2018