Trial Outcomes & Findings for Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma (NCT NCT00566228)
NCT ID: NCT00566228
Last Updated: 2018-07-09
Results Overview
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.
COMPLETED
PHASE3
122 participants
Date of infusion to disease progression, relapse, or death from any cause whichever came first, assessed up to 24 months post enrollment.
2018-07-09
Participant Flow
Participant milestones
| Measure |
Immunologic Autograft Engineering
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
60
|
|
Overall Study
COMPLETED
|
56
|
55
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Immunologic Autograft Engineering
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Attempt to mobilize stem cells failed
|
2
|
2
|
|
Overall Study
Unable to collect sufficient CD34 cells
|
3
|
2
|
|
Overall Study
progressed before infusion could occur
|
0
|
1
|
Baseline Characteristics
Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Immunologic Autograft Engineering
n=61 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=60 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
58 years
n=107 Participants
|
58 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Immunologic Autograft Engineering
n=56 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=55 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Median Progression-free Survival
|
NA months
The median and 95% confidence interval was not reached.
|
NA months
The median and 95% confidence interval was not reached.
|
SECONDARY outcome
Timeframe: Date of infusion to disease progression, relapse, or death from any cause, up to one yearProgression-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).
Outcome measures
| Measure |
Immunologic Autograft Engineering
n=56 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=55 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Progression-free Survival Rate at 1 Year
|
73.1 percentage of patients
Interval 62.3 to 85.7
|
65.4 percentage of patients
Interval 53.9 to 79.3
|
SECONDARY outcome
Timeframe: Date of infusion to disease progression, relapse, or death from any cause, up to two yearsProgression-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).
Outcome measures
| Measure |
Immunologic Autograft Engineering
n=56 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=55 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Progression-free Survival Rate at 2 Years
|
57.9 percentage of patients
Interval 46.1 to 72.7
|
65.4 percentage of patients
Interval 53.9 to 79.3
|
SECONDARY outcome
Timeframe: date of infusion to death from any cause, up to one yearOverall 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.
Outcome measures
| Measure |
Immunologic Autograft Engineering
n=56 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=55 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
One-year Overall Survival Rate
|
91.1 percentage of patients
Interval 83.9 to 98.9
|
83.6 percentage of patients
Interval 74.4 to 94.0
|
SECONDARY outcome
Timeframe: Up to 30 days after autologous peripheral hematopoietic stem cell transplantationThe 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.
Outcome measures
| Measure |
Immunologic Autograft Engineering
n=56 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=55 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Median Time to Absolute Lymphocyte Count Engraftment
|
14 days
Interval 10.0 to 30.0
|
14 days
Interval 10.0 to 30.0
|
SECONDARY outcome
Timeframe: 5 to 7 days after patient received granulocyte-colony stimulating factor and reached a peripheral CD34 count of 10 cells/microliter or greaterFive (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.
Outcome measures
| Measure |
Immunologic Autograft Engineering
n=56 Participants
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=55 Participants
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Median Number of CD34 Cells/kg Infused
|
4.6 x10^6 cells/kg
Interval 2.0 to 8.2
|
5.3 x10^6 cells/kg
Interval 3.0 to 11.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineEvaluation 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
Outcome measures
Outcome data not reported
Adverse Events
Immunologic Autograft Engineering
Standard Autograft Collection
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Immunologic Autograft Engineering
n=57 participants at risk
Patients' stem cells are collected according to modified Amicus settings (i.e., MNC OFFSET = 0.0 and RBC = 7.0).
|
Standard Autograft Collection
n=57 participants at risk
Patients' stem cells are collected according to standard Amicus settings (i.e., MNC OFFSET = 1.5 and RBC OFFSET = 5.0).
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
8.8%
5/57 • Number of events 5 • At completion of apheresis collection; Up to 2 years.
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).
|
7.0%
4/57 • Number of events 4 • At completion of apheresis collection; Up to 2 years.
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).
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
1/57 • Number of events 1 • At completion of apheresis collection; Up to 2 years.
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).
|
0.00%
0/57 • At completion of apheresis collection; Up to 2 years.
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).
|
|
Cardiac disorders
Atrial tachycardia
|
1.8%
1/57 • Number of events 1 • At completion of apheresis collection; Up to 2 years.
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).
|
0.00%
0/57 • At completion of apheresis collection; Up to 2 years.
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).
|
|
General disorders
Injection site reaction
|
0.00%
0/57 • At completion of apheresis collection; Up to 2 years.
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).
|
5.3%
3/57 • Number of events 3 • At completion of apheresis collection; Up to 2 years.
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).
|
|
Injury, poisoning and procedural complications
Bruising
|
19.3%
11/57 • Number of events 11 • At completion of apheresis collection; Up to 2 years.
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).
|
15.8%
9/57 • Number of events 9 • At completion of apheresis collection; Up to 2 years.
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).
|
|
Investigations
Platelet count decreased
|
10.5%
6/57 • Number of events 6 • At completion of apheresis collection; Up to 2 years.
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).
|
7.0%
4/57 • Number of events 4 • At completion of apheresis collection; Up to 2 years.
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).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.8%
5/57 • Number of events 5 • At completion of apheresis collection; Up to 2 years.
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).
|
10.5%
6/57 • Number of events 6 • At completion of apheresis collection; Up to 2 years.
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place