Trial Outcomes & Findings for Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD (NCT NCT00914940)
NCT ID: NCT00914940
Last Updated: 2020-08-20
Results Overview
Number of participants with aGVHD and severity of aGVHD within the first 360 days post-transplant as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease, Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Within 360 days of transplant
Results posted on
2020-08-20
Participant Flow
Participants were recruited based on physician referral at 2 academic medical centers between Dec 2009 and Oct 2014. The first patient was enrolled on December 17, 2009 and the last participant was enrolled in October 2014
Participant milestones
| Measure |
Overall Study Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
D0 to D100 Post-transplant
STARTED
|
41
|
|
D0 to D100 Post-transplant
COMPLETED
|
39
|
|
D0 to D100 Post-transplant
NOT COMPLETED
|
2
|
|
D101 to 2 Years Post-transplant
STARTED
|
39
|
|
D101 to 2 Years Post-transplant
COMPLETED
|
31
|
|
D101 to 2 Years Post-transplant
NOT COMPLETED
|
8
|
|
2 Years to 5 Years Post-transplant
STARTED
|
31
|
|
2 Years to 5 Years Post-transplant
COMPLETED
|
28
|
|
2 Years to 5 Years Post-transplant
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Study Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
D0 to D100 Post-transplant
Death
|
2
|
|
D101 to 2 Years Post-transplant
Death
|
8
|
|
2 Years to 5 Years Post-transplant
Death
|
3
|
Baseline Characteristics
Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=41 Participants
CONDITIONING: Patients receive TBI twice per day on days -10 to -7, then thiotepa IV administered over approximately 4 hours on days -6 and -5, and fludarabine IV administered over 30 minutes on days -6 to -2.
DONOR BONE MARROW TRANSPLANTATION: GCSF-mobilized CD34 enriched PBSC and CD45RA depleted cells infused on day 0.
POST-TRANSPLANT IMMUNOSUPPRESSION: Ptients receive tacrolimus beginning on day -1 by continuous IV infusion, converting to oral formulation when oral feeding is established. If there is no evidence of grade II-IV acute GVHD prior to day 50, tacrolimus is then tapered.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 360 days of transplantNumber of participants with aGVHD and severity of aGVHD within the first 360 days post-transplant as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease, Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening.
Outcome measures
| Measure |
Overall Study Participants
n=41 Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
No acute GVHD
|
11 Participants
|
|
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
Grade I acute GVHD
|
2 Participants
|
|
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
Grade II acute GVHD
|
25 Participants
|
|
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
Grade III acute GVHD
|
3 Participants
|
|
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
Grade IV acute GVHD
|
0 Participants
|
|
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
Steroid refractory acute GVHD
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post transplantGraft failure is defined as either a failure to reach an ANC of \>500/uL for 3 consecutive days by day 28 post-transplant, or an irreversible decrease in ANC \<100 after an established donor graft, unless there is a reasonable explanation such as a viral infection or drug effect that may be responsible for a reversible decrease in ANC.
Outcome measures
| Measure |
Overall Study Participants
n=41 Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant
|
0 Participants
|
SECONDARY outcome
Timeframe: Transplant to day 100Number of participants who died due to transplant-related issues within the first 100 days of transplant
Outcome measures
| Measure |
Overall Study Participants
n=41 Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Transplant-related Mortality by Day 100
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post transplantRelapse is defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology. Testing for recurrent malignancy in the blood and bone marrow performed by monitoring the CBC and bone marrow at Day 28, 58, 80, 360, and as needed for suspected relapse.
Outcome measures
| Measure |
Overall Study Participants
n=41 Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post transplantPopulation: Participants alive and without relapse at D100
Chronic GVHD measured by meeting NIH criteria and treated with immune suppression
Outcome measures
| Measure |
Overall Study Participants
n=38 Participants
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Number of Participants With Chronic GVHD
Chronic GVHD that meets NIH criteria
|
3 Participants
|
|
Number of Participants With Chronic GVHD
No documented chronic GVHD
|
35 Participants
|
Adverse Events
Overall Study Participants
Serious events: 39 serious events
Other events: 41 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Overall Study Participants
n=41 participants at risk
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.8%
4/41 • Number of events 4 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Metabolism and nutrition disorders
Anorexia
|
7.3%
3/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Bladder infection
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
4.9%
2/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Catheter related infection
|
22.0%
9/41 • Number of events 9 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
3/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Duodenal infection
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Musculoskeletal and connective tissue disorders
Generalized muslce weakness
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Vascular disorders
Hypotension
|
17.1%
7/41 • Number of events 7 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.3%
3/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Coagulase-negative staph bacteremia
|
19.5%
8/41 • Number of events 8 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Clostridium difficile infection
|
7.3%
3/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
CMV reactivation
|
48.8%
20/41 • Number of events 20 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
E Coli Bacteremia
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Leptotrichia buccalis infection
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
MRSA bacteremia
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Candida Glabrata
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Enterococcus faecium
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Strep mitis
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Strep Viridans
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
VRE bacteremia
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Lung infection
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Mucositis, oral
|
87.8%
36/41 • Number of events 37 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Nausea
|
7.3%
3/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Cardiac disorders
Pericarditis
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Rectal pain
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.9%
2/41 • Number of events 2 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Sepsis
|
7.3%
3/41 • Number of events 3 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/41 • Number of events 1 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
Other adverse events
| Measure |
Overall Study Participants
n=41 participants at risk
CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
19.5%
8/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Investigations
Lymphocyte count decreased
|
82.9%
34/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Investigations
Neutrophil count decreased
|
39.0%
16/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Investigations
Platelet count decreased
|
31.7%
13/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Investigations
White blood cell decreased
|
36.6%
15/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.6%
15/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.2%
5/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.6%
6/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Investigations
CD4 lymphocytes decreased
|
80.5%
33/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Diarrhea
|
46.3%
19/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Vascular disorders
Hypertenstion
|
26.8%
11/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.2%
5/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
8/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.2%
5/41 • AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
|
Additional Information
Marie Bleakley, MD
Fred Hutchinson Cancer Research Center
Phone: 206-667-6572
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place