Trial Outcomes & Findings for Donor Stem Cell Transplantation for Congenital Immunodeficiencies (NCT NCT00426517)
NCT ID: NCT00426517
Last Updated: 2021-05-11
Results Overview
Engraftment of allogeneic or matched unrelated (including cord blood) hematopoietic progenitor cells using moderate-dose busulfan and Campath-1H with or without whole body irradiation so as to attain phenotypic correction of congenital immunodeficiencies.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
48 participants
Primary outcome timeframe
1 year
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
Matched Related Donor Stem Cell Transplant
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
36
|
3
|
2
|
|
Overall Study
COMPLETED
|
7
|
36
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplantation for Congenital Immunodeficiencies
Baseline characteristics by cohort
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The analyses include only those who underwent transplant
Engraftment of allogeneic or matched unrelated (including cord blood) hematopoietic progenitor cells using moderate-dose busulfan and Campath-1H with or without whole body irradiation so as to attain phenotypic correction of congenital immunodeficiencies.
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Stem Cell Transplant Engraftment
|
7 Participants
|
31 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearParticipants who achieved engraftment without development of graft versus host disease (GVHD).
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Engraftment Without Development of GVHD
|
6 Participants
|
30 Participants
|
3 Participants
|
NA Participants
Subjects did not engraft
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants with myeloid chimerism of greater than 10% of donor cells at 1 year post transplant
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Participants With Established Stable Mixed Chimerism
|
7 Participants
|
30 Participants
|
3 Participants
|
NA Participants
Subjects did not engraft
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analyses include only those who underwent transplant
Rapidity of immune reconstitution based on number of days to CD3 count greater than 100 u/L.
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Days to CD3 Count Greater Than 100 u/L
|
355 Days
Standard Deviation 201.8
|
284 Days
Standard Deviation 296.64
|
16 Days
Standard Deviation 3.46
|
NA Days
Standard Deviation NA
Subjects did not engraft
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analyses include only those who underwent transplant
Recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 x 109 /L (500/mm3 ) for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 x 109 /L.
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Days to Absolute Neutrophil Recovery (ANC)
|
19.42 Days
Standard Deviation 4.57
|
77.44 Days
Standard Deviation 192.34
|
25.5 Days
Standard Deviation 15.88
|
NA Days
Standard Deviation NA
Subjects did not engraft
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analyses include only those who underwent transplant
Average number of red blood cell (RBC) transfusion per subject
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Number of RBC Transfusions Per Subject
|
1.71 transfusions per person
Standard Deviation 1.79
|
7.08 transfusions per person
Standard Deviation 12.18
|
4 transfusions per person
Standard Deviation 1
|
NA transfusions per person
Standard Deviation NA
Subjects did not engraft
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analyses include only those who underwent transplant
Platelet recovery is defined as platelet value ≥ 20 × 109/L for three consecutive days and no platelet transfusions administered for previous seven consecutive days. The date of platelet recovery is the date of the first of three consecutive laboratory values ≥ 20 × 109/L.
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Days to Platelet Recovery
|
31 Days
Standard Deviation 20.21
|
31.9 Days
Standard Deviation 30.48
|
32.6 Days
Standard Deviation 20.31
|
NA Days
Standard Deviation NA
Subjects did not engraft
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analyses include only those who underwent transplant
Number of events of Cytomegalovirus disease based on clinical sequelae that requires treatment (not reactivation)
Outcome measures
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 Participants
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 Participants
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Incidence of Cytomegalovirus (CMV) Disease
|
0 Number of events
Standard Deviation 0
|
0 Number of events
Standard Deviation 0
|
0 Number of events
Standard Deviation 0
|
0 Number of events
Standard Deviation 0
|
Adverse Events
Matched Related Donor Stem Cell Transplant
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Matched Unrelated Donor Stem Cell Transplant
Serious events: 4 serious events
Other events: 17 other events
Deaths: 9 deaths
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 participants at risk
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 participants at risk
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 participants at risk
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 participants at risk
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Evans syndrome
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Blood and lymphatic system disorders
Post transplant lymphoproliferative disorder
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Injury, poisoning and procedural complications
Engraft failure
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
14.3%
1/7 • 2 years
|
0.00%
0/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
Other adverse events
| Measure |
Matched Related Donor Stem Cell Transplant
n=7 participants at risk
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 10 mg/kg total dose given intravenously over 2 days
|
Matched Unrelated Donor Stem Cell Transplant
n=36 participants at risk
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
Matched Unrelated Donor Stem Cell Transplant (MUD-non CGD)
n=3 participants at risk
Conditioning with ATG 40 mg/kg total dose over 4 days IV, Busulfan 5 mg/kg total dose over 2 days IV, and TBI 300 cGy in two fractions at day -2
|
Matched Unrelated Donor Transplant (MUD-CGD) Cord Blood
n=2 participants at risk
Conditioning with Campath 1 mg/kg total dose given intravenously over 5 days, Busulfan 5 mg/kg total dose given intravenously over 2 days, and Total Body Irradiation (TBI) 200 cGy in two fractions on the same day
|
|---|---|---|---|---|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/7 • 2 years
|
5.6%
2/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Gastrointestinal disorders
Acute graft versus host disease in intestine
|
14.3%
1/7 • 2 years
|
5.6%
2/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Immune system disorders
Chronic graft versus host disease
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Immune system disorders
Chronic graft versus host disease in skin
|
14.3%
1/7 • 2 years
|
5.6%
2/36 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Infections and infestations
Catheter site infection
|
14.3%
1/7 • 2 years
|
13.9%
5/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Injury, poisoning and procedural complications
Engraft failure
|
0.00%
0/7 • 2 years
|
13.9%
5/36 • 2 years
|
0.00%
0/3 • 2 years
|
100.0%
2/2 • 2 years
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/7 • 2 years
|
2.8%
1/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Reproductive system and breast disorders
Ovarian disorder
|
14.3%
1/7 • 2 years
|
5.6%
2/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Acute graft versus host disease in skin
|
0.00%
0/7 • 2 years
|
8.3%
3/36 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/2 • 2 years
|
Additional Information
Kang, Elizabeth
National Institute of Allergy and Infectious Diseases
Phone: +1 301 402 7567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place