Trial Outcomes & Findings for Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer (NCT NCT00923845)
NCT ID: NCT00923845
Last Updated: 2017-09-29
Results Overview
Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
6 Months Post-Transplant (Day +100)
Results posted on
2017-09-29
Participant Flow
Participant milestones
| Measure |
Donors
A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
|
Recipients
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Donor Lymphocyte Harvest
STARTED
|
13
|
0
|
|
Donor Lymphocyte Harvest
COMPLETED
|
13
|
0
|
|
Donor Lymphocyte Harvest
NOT COMPLETED
|
0
|
0
|
|
Donor Hematopoietic Stem Cell Harvest
STARTED
|
13
|
0
|
|
Donor Hematopoietic Stem Cell Harvest
COMPLETED
|
13
|
0
|
|
Donor Hematopoietic Stem Cell Harvest
NOT COMPLETED
|
0
|
0
|
|
Induction Therapy
STARTED
|
0
|
12
|
|
Induction Therapy
COMPLETED
|
0
|
10
|
|
Induction Therapy
NOT COMPLETED
|
0
|
2
|
|
Allogeneic Stem Cell Therapy
STARTED
|
0
|
10
|
|
Allogeneic Stem Cell Therapy
Received Each of 3 Planned T-Rapa DLI
|
0
|
8
|
|
Allogeneic Stem Cell Therapy
Received More Unmanipulated DLI for PD
|
0
|
6
|
|
Allogeneic Stem Cell Therapy
COMPLETED
|
0
|
10
|
|
Allogeneic Stem Cell Therapy
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Donors
A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
|
Recipients
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Induction Therapy
Poor performance status
|
0
|
2
|
Baseline Characteristics
Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer
Baseline characteristics by cohort
| Measure |
Donors
n=13 Participants
A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
|
Recipients
n=12 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
53.14 years
STANDARD_DEVIATION 9.06 • n=5 Participants
|
58.03 years
STANDARD_DEVIATION 8.01 • n=7 Participants
|
55.48 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 Months Post-Transplant (Day +100)Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))
Partial Response (PR)
|
0 participants
|
—
|
|
Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))
Complete Response (CR)
|
0 participants
|
—
|
|
Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))
Progressive Disease (PD)
|
8 participants
|
—
|
|
Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))
Stable Disease (SD)
|
1 participants
|
—
|
|
Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))
Not Applicable (NA)
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 50 months and 6 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Recipient
n=13 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
n=12 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Count of Participants With Adverse Events
|
0 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During the 21-day PC regimenAbsolute neutrophil count determination by complete blood count methodology (Absolute Neutrophil Count (ANC) \< 500 Cells/µL).
Outcome measures
| Measure |
Recipient
n=12 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 21-day PC regimenOccurrence of infection by Common Terminology Criteria for Adverse Events (CTCAE).
Outcome measures
| Measure |
Recipient
n=12 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)Reduction in cluster of differentiation 4 (CD4)+ T cells \[change in median values and (range of values)\].
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Immune Depletion in Cluster of Differentiation 4 (CD4) Cells
Baseline
|
503 Cells/µL
Interval 124.0 to 1487.0
|
—
|
|
Immune Depletion in Cluster of Differentiation 4 (CD4) Cells
Day 21
|
54 Cells/µL
Interval 10.0 to 107.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)Reduction in cluster of differentiation 8 (CD8)+ T cells \[change in median values and (range of values)\].
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells
Baseline
|
239 cells/µL
Interval 56.0 to 770.0
|
—
|
|
Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells
Day 21
|
45 cells/µL
Interval 12.0 to 131.0
|
—
|
SECONDARY outcome
Timeframe: Cytokine analysis at baseline and within 24 hours of completion of the pentostatin/cyclophosphamide regimenImmune suppression is defined by the frequency of elimination of a pre-transplant T cell cytokine value.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Immune Suppression
Negative at baseline
|
0 % of undetectable cytokine measurements
|
—
|
|
Immune Suppression
Positive at baseline
|
100 % of undetectable cytokine measurements
|
—
|
|
Immune Suppression
Positive 24 hours after regimen
|
0 % of undetectable cytokine measurements
|
—
|
|
Immune Suppression
Negative 24 hours after regimen
|
100 % of undetectable cytokine measurements
|
—
|
SECONDARY outcome
Timeframe: Days 14, 28, 45, and 60 post transplantDonor Genetic Elements by variable number tandem repeat-polymerase chain reaction (VNTR-PCR) Analysis.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 14 donor T cell chimerism
|
61 Percent Donor by VNTR-PCR Analysis
Interval 7.0 to 77.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 28 donor T cell chimerism
|
72 Percent Donor by VNTR-PCR Analysis
Interval 9.0 to 91.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 45 donor T cell chimerism
|
74 Percent Donor by VNTR-PCR Analysis
Interval 21.0 to 88.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 60 donor T cell chimerism
|
77 Percent Donor by VNTR-PCR Analysis
Interval 26.0 to 95.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 14 myeloid cell chimerism
|
0 Percent Donor by VNTR-PCR Analysis
Interval 0.0 to 27.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 28 myeloid cell chimerism
|
13 Percent Donor by VNTR-PCR Analysis
Interval 4.0 to 50.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 45 myeloid cell chimerism
|
18 Percent Donor by VNTR-PCR Analysis
Interval 11.0 to 67.0
|
—
|
|
Engraftment Donor T Cell and Myeloid Cell Chimerism
Day 60 myeloid cell chimerism
|
26 Percent Donor by VNTR-PCR Analysis
Interval 13.0 to 76.0
|
—
|
SECONDARY outcome
Timeframe: 100 days post transplantAcute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: \<25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin \>15 mg/dl = 4)).
Outcome measures
| Measure |
Recipient
n=12 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 100 days post-transplant through 5 years post-transplantPopulation: Only 6 patients were evaluable for this endpoint due to death due to malignancy.
Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: \<25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin \>15 mg/dl = 4)).
Outcome measures
| Measure |
Recipient
n=6 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: For the duration of post-transplant follow-upPopulation: Only 4 patients were evaluable due to mortality from malignancy.
Chronic GVHD was assessed by the 2005 Chronic GVHD Consensus Project. Chronic GVHS may include dryness of the mouth and eyes, weight loss, liver damage and lung damage leading to cough and shortness of breath (i.e. skin Grading: no symptoms = 0, \<18% body surface area (BSA) = 1, 19-50% BSA = 2, and \>50% BSA = 3); oral cavity Grading: no symptoms = 0, mild symptoms = 1, moderate symptoms =2 and severe symptoms =3)).
Outcome measures
| Measure |
Recipient
n=4 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Count of Patients With Chronic Graft Versus Host Disease (GVHD)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 14, 60, and 100 post transplantPopulation: The values for each subset were stable at days 60 and 100 relative to day 14 values.
CD4 T Cells immune reconstitution is defined as distribution of CD4+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution
Day 14
|
22 Percentage of total CD4 cell subsets
Standard Deviation 3
|
—
|
|
Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution
Day 60
|
20 Percentage of total CD4 cell subsets
Standard Deviation 2
|
—
|
|
Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution
Day 100
|
19 Percentage of total CD4 cell subsets
Standard Deviation 2
|
—
|
SECONDARY outcome
Timeframe: Days 14, 60, and 100 post transplantPopulation: The values for each subset were stable at days 60 and 100 relative to day 14 values.
CD8+ T Cells immune reconstitution is defined as distribution of CD8+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution
Day 14
|
6 Percent of total CD8 cell subsets
Standard Deviation 1
|
—
|
|
Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution
Day 60
|
5 Percent of total CD8 cell subsets
Standard Deviation 1
|
—
|
|
Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution
Day 100
|
4 Percent of total CD8 cell subsets
Standard Deviation 1
|
—
|
SECONDARY outcome
Timeframe: Days 14, 60 and 100 post transplantPopulation: The values for each subset were stable at days 60 and 100 relative to day 14 values.
Intra-cellular flow cytometry detection of GATA3 transcription factor.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)
Day 14
|
42 Percentage of total CD4+ T cells
Interval 31.0 to 64.0
|
—
|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)
Day 60
|
37 Percentage of total CD4+ T cells
Interval 28.0 to 44.0
|
—
|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)
Day 100
|
43 Percentage of total CD4+ T cells
Interval 20.0 to 49.0
|
—
|
SECONDARY outcome
Timeframe: Days 14, 60, and 100 post transplantPopulation: The values for each subset were stable at days 60 and 100 relative to day 14 values.
CD4+ T cells were analyzed by flow cytometry for intracellular detection of Tbet transcription factor.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet
Day 14
|
8 Percentage of total CD4+T cells
Interval 3.0 to 16.0
|
—
|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet
Day 60
|
8 Percentage of total CD4+T cells
Interval 1.0 to 17.0
|
—
|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet
Day 100
|
6 Percentage of total CD4+T cells
Interval 2.0 to 19.0
|
—
|
SECONDARY outcome
Timeframe: Days 14, 60, and 100 post transplantPopulation: The values for each subset were stable at days 60 and 100 relative to day 14 values.
CD4+ T cells were analyzed by flow cytometry for intracellular expression of FoxP3.
Outcome measures
| Measure |
Recipient
n=10 Participants
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
Recipient
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))
Day 14
|
8 Percentage of total CD4+ T cells
Interval 4.0 to 14.0
|
—
|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))
Day 60
|
6 Percentage of total CD4+ T cells
Interval 1.0 to 13.0
|
—
|
|
Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))
Day 100
|
3 Percentage of total CD4+ T cells
Interval 1.0 to 10.0
|
—
|
Adverse Events
Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recipient
Serious events: 8 serious events
Other events: 12 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Donor
n=13 participants at risk
A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
|
Recipient
n=12 participants at risk
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
General disorders
Death not associated with CTCAE term::Death NOS
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
General disorders
Death not associated with CTCAE term::Disease progression NOS
|
0.00%
0/13 • 50 months and 6 days
|
41.7%
5/12 • Number of events 5 • 50 months and 6 days
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Lower GI NOS
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Renal and urinary disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
Other adverse events
| Measure |
Donor
n=13 participants at risk
A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
|
Recipient
n=12 participants at risk
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
|
|---|---|---|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/13 • 50 months and 6 days
|
41.7%
5/12 • Number of events 18 • 50 months and 6 days
|
|
Hepatobiliary disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/13 • 50 months and 6 days
|
50.0%
6/12 • Number of events 44 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 3 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Adrenal insufficiency
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Hepatobiliary disorders
Albumin, serum-low (hypoalbuminemia)
|
0.00%
0/13 • 50 months and 6 days
|
41.7%
5/12 • Number of events 15 • 50 months and 6 days
|
|
Hepatobiliary disorders
Alkaline phosphatase
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 3 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Amylase
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 3 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 4 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Cardiac disorders
Cardiac General - Other
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 4 • 50 months and 6 days
|
|
Nervous system disorders
Confusion
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 4 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Renal and urinary disorders
Creatinine
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 3 • 50 months and 6 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 3 • 50 months and 6 days
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 3 • 50 months and 6 days
|
|
Cardiac disorders
Edema: limb
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/13 • 50 months and 6 days
|
41.7%
5/12 • Number of events 5 • 50 months and 6 days
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
General disorders
Growth and Development - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/13 • 50 months and 6 days
|
75.0%
9/12 • Number of events 61 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 3 • 50 months and 6 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Cecum/appendix
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Liver
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Hemorrhage, GI::Rectum
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Renal and urinary disorders
Hemorrhage, GU::Urinary NOS
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 3 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Cardiac disorders
Hypertension
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Cardiac disorders
Hypotension
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/13 • 50 months and 6 days
|
33.3%
4/12 • Number of events 6 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Infections and infestations
Infection - Other
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 4 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Ungual (nails)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Renal and urinary disorders
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 3 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Infection with unknown ANC::Blood
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC::Lung (pneumonia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Infection with unknown ANC::Small bowel NOS
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC::Trachea
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
0.00%
0/13 • 50 months and 6 days
|
66.7%
8/12 • Number of events 43 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Nervous system disorders
Mood alteration::Anxiety
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Nervous system disorders
Mood alteration::Depression
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 3 • 50 months and 6 days
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/13 • 50 months and 6 days
|
33.3%
4/12 • Number of events 4 • 50 months and 6 days
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/13 • 50 months and 6 days
|
50.0%
6/12 • Number of events 25 • 50 months and 6 days
|
|
Eye disorders
Ocular/Visual - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 3 • 50 months and 6 days
|
|
General disorders
Pain - Other
|
0.00%
0/13 • 50 months and 6 days
|
41.7%
5/12 • Number of events 5 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Buttock
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest wall
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Chest/thorax NOS
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Nervous system disorders
Pain::Head/headache
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Musculoskeletal and connective tissue disorders
Pain::Joint
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Gastrointestinal disorders
Pain::Oral cavity
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
General disorders
Pain::Pain NOS
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Reproductive system and breast disorders
Pain::Pelvis
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/13 • 50 months and 6 days
|
66.7%
8/12 • Number of events 25 • 50 months and 6 days
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/13 • 50 months and 6 days
|
41.7%
5/12 • Number of events 60 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/13 • 50 months and 6 days
|
33.3%
4/12 • Number of events 4 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 3 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/13 • 50 months and 6 days
|
25.0%
3/12 • Number of events 4 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 2 • 50 months and 6 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/13 • 50 months and 6 days
|
58.3%
7/12 • Number of events 34 • 50 months and 6 days
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Cardiac disorders
Syncope (fainting)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
General disorders
Syndromes - Other
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Cardiac disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/13 • 50 months and 6 days
|
33.3%
4/12 • Number of events 5 • 50 months and 6 days
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 5 • 50 months and 6 days
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 1 • 50 months and 6 days
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 2 • 50 months and 6 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 50 months and 6 days
|
8.3%
1/12 • Number of events 12 • 50 months and 6 days
|
|
General disorders
Weight loss
|
0.00%
0/13 • 50 months and 6 days
|
16.7%
2/12 • Number of events 4 • 50 months and 6 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place