Trial Outcomes & Findings for Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow (NCT NCT00003838)
NCT ID: NCT00003838
Last Updated: 2023-09-21
Results Overview
Number of Participants who experienced transplant related mortality by Day 200
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
202 participants
Primary outcome timeframe
200 days
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Donor
The HLA matched donor will receive granulocyte colony-stimulating factor (G-CSF) with apheresis collections of peripheral blood progenitor cells on day 5 and day 6 if required.
G-CSF will be administered based on body weight for at least 5, and up to 7 days, subcutaneously.
|
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
102
|
43
|
57
|
|
Overall Study
COMPLETED
|
102
|
18
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
25
|
8
|
Reasons for withdrawal
| Measure |
Donor
The HLA matched donor will receive granulocyte colony-stimulating factor (G-CSF) with apheresis collections of peripheral blood progenitor cells on day 5 and day 6 if required.
G-CSF will be administered based on body weight for at least 5, and up to 7 days, subcutaneously.
|
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
12
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Disease Progression
|
0
|
12
|
0
|
Baseline Characteristics
Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
Baseline characteristics by cohort
| Measure |
Donor
n=102 Participants
The HLA matched donor will receive granulocyte colony-stimulating factor (G-CSF) with apheresis collections of PBPC on day 5 and day 6 if required.
G-CSF: G-CSF will be administered based on body weight for at least 5, and up to 7 days, subcutaneously.
|
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=43 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously (IV) daily x 5 days followed by a peripheral blood hematopoietic progenitor cell (PBPC) graft targeted to deliver \>5x10\^6 CD34+ cells/kg
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic BMT but where concern for a high procedural mortality with conventional Bone Marrow Transplant will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously (IV) daily x 5 days followed by a peripheral blood hematopoietic progenitor cell (PBPC) graft targeted to deliver \>5x10\^6 CD34+ cells/kg
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
83 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
43 participants
n=7 Participants
|
57 participants
n=5 Participants
|
202 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 200 daysPopulation: The analyses included only those participants who had a transplant.
Number of Participants who experienced transplant related mortality by Day 200
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=43 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Number of Participants Who Experienced Transplant Related Mortality
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 100Population: Alive participants who had a transplant with data available for analysis
Number of participants with complete donor myeloid chimerism. Myeloid (CD34+) and T-cell (CD3+) chimerisms were determined by PCR analysis of short tandem repeats (STR). Complete donor chimerism is defined as \>95% donor-derived cells in the peripheral blood in a specific lineage.
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=31 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism
complete donor myeloid (CD34+) chimerism
|
29 Participants
|
55 Participants
|
|
Number of Participants With Complete Donor Myeloid (CD34+) and T-cell (CD3+) Chimerism
complete T-cell (CD3+) chimerism
|
30 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Day 30Population: Alive participants who had a transplant with data available for analysis
Median days to neutrophil recovery. Neutrophil recovery is defined as the first day of two consecutive days in which the ANC was 500 K/ml or greater unsupported by growth factors or granulocyte transfusion.
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=39 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=56 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Median Days to Neutrophil Engraftment
|
14 Days
Interval 7.0 to 22.0
|
15 Days
Interval 6.0 to 24.0
|
SECONDARY outcome
Timeframe: Up to Day 100Population: analysis performed as intention to treat
Number of participants who experienced acute GVHD grades II-IV Acute-GVHD was graded and staged prospectively using criteria from the 1994 Consensus Conference on Acute-GVHD Grading. Grades are defined as: Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day. Grade III: Skin = Rash on \>50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea \> 1500 mL/day. Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin \>15 mg/dL; Lower GI = Severe abdominal pain with or without ileus. Grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=43 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Number of Participants Who Experienced Acute GVHD Grades II-IV
Grade II
|
6 Participants
|
16 Participants
|
|
Number of Participants Who Experienced Acute GVHD Grades II-IV
Grade III-IV
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 100 up to 3 yearsPopulation: The analyses included only those participants that engrafted and survived over 100 days
Number of participant who experienced chronic graft versus host disease (GVHD) following stem cell transplant The diagnosis of clinical features of chronic-GVHD was determined prospectively and classified retrospectively into limited or extensive based on the Revised Seattle Classification. Chronic GvHD severity categorized as "limited" is defined as: localized skin lesions with or without limited hepatic involvement and "extensive" is defined as: generalized skin involvement, major hepatic complications, or involvement of any other organ.
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=38 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=55 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Number of Participant Who Experienced Chronic Graft Versus Host Disease Following Stem Cell Transplant
Limited
|
12 Participants
|
13 Participants
|
|
Number of Participant Who Experienced Chronic Graft Versus Host Disease Following Stem Cell Transplant
Extensive
|
19 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: enrollment to date of death, up to 5 yearsPopulation: The analyses included only those participants that had a stem cell transplant
Number of participants overall survival. Overall survival is defined as number participants alive following stem cell transplant
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=43 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Number of Participants Overall Survival
|
17 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The analyses included only those participants that had a stem cell transplant
Number of participants that remained Disease-free survival following stem cell transplant. Disease-free survival is defined as survival free of disease relapse or disease progression following stem cell transplant.
Outcome measures
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=43 Participants
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 Participants
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
|---|---|---|
|
Number of Participants That Remained Disease-free Survival
|
26 Participants
|
56 Participants
|
Adverse Events
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
Serious events: 41 serious events
Other events: 0 other events
Deaths: 26 deaths
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
Serious events: 47 serious events
Other events: 0 other events
Deaths: 9 deaths
Donor
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Stem Cell Transplant in High Risk for Transplant Related Complications and Mortality
n=43 participants at risk
Participants at high risk for transplant related complications and mortality will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Group B: Stem Cell Transplant in Debilitating Hematologic Diseases
n=57 participants at risk
Participants with hematologic diseases associated with reasonable longevity, shown to be curable by allogeneic Bone Marrow Transplant (BMT) but where concern for a high procedural mortality with conventional BMT will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m\^2 intravenously daily x 5 days followed by a peripheral blood hematopoietic progenitor cell graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
|
Donor
n=101 participants at risk
The HLA matched donor will receive granulocyte colony-stimulating factor (G-CSF) with apheresis collections of peripheral blood progenitor cells on day 5 and day 6 if required.
G-CSF will be administered based on body weight for at least 5, and up to 7 days, subcutaneously.
|
|---|---|---|---|
|
Immune system disorders
Acute Gastrointestional Graft Verses Host Disease
|
18.6%
8/43 • Number of events 8 • 5 years
|
15.8%
9/57 • Number of events 14 • 5 years
|
—
0/0 • 5 years
|
|
Immune system disorders
Acute Graft verses Host Disease of Skin
|
0.00%
0/43 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Cardiac disorders
Acute Myocardial Infarction
|
4.7%
2/43 • Number of events 2 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Renal and urinary disorders
Acute on Chronic Renal Failure
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Acute peritonitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Acute right parietal/occipital lobe hemorrhage
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Acute Upper Gastrointestional Graft Verses Host Disease
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Adenoviral enteritis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Allergic reaction to medication
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar infiltrates
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Surgical and medical procedures
Appendecitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/43 • 5 years
|
3.5%
2/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
ATG induced anaphylactic reaction
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
ATG induced reaction
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
Axonal polyneuropathy cyclosporine induced
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Bacteremia
|
16.3%
7/43 • Number of events 8 • 5 years
|
15.8%
9/57 • Number of events 18 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Bilateral Lung Infiltrates
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Blood and lymphatic system disorders
Bone Marrow positive for megakaryocytes
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Catheter Related Thrombosus
|
4.7%
2/43 • Number of events 2 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/43 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/43 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Chronic Graft Verses Host Disease
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Chronic Graft Verses Host Disease of Liver
|
4.7%
2/43 • Number of events 2 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Chronic Graft Verses Host Disease of Lungs
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Chronic Graft Verses Host Disease of Skin
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Skin and subcutaneous tissue disorders
Chronic left ankle ulcer osteomyelitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Clostridioides difficile
|
2.3%
1/43 • Number of events 1 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
CMV colitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
CMV Reactivation
|
7.0%
3/43 • Number of events 3 • 5 years
|
7.0%
4/57 • Number of events 4 • 5 years
|
0.00%
0/101 • 5 years
|
|
Investigations
Cold Symptoms
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Community Acquired Pneumonia
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Eye disorders
Conjunivitis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
3/43 • Number of events 3 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar hemorrhage
|
0.00%
0/43 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Disease progression
|
7.0%
3/43 • Number of events 3 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Disseminated zoster
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Ear Infection
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Emesis
|
2.3%
1/43 • Number of events 1 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.99%
1/101 • Number of events 1 • 5 years
|
|
Immune system disorders
Engraftment Syndrome
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Enterovirus
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Epstein-Barr virus
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Erosive gastritis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of Chronic Obstructive Pulmonary Disease with Upper Respirtory Infection
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Fatigue
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Fever
|
9.3%
4/43 • Number of events 4 • 5 years
|
7.0%
4/57 • Number of events 4 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Fluid Overload
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Blood and lymphatic system disorders
Glomerular microangiopathic thrombosis suggestive of hemolytic uremia syndrome
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Graft verses host disease reactivation
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Surgical and medical procedures
Hemoptysis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Hepatitis B reactivation
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Herpes zoster reactivation
|
0.00%
0/43 • 5 years
|
5.3%
3/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Investigations
Hyperglycemia
|
2.3%
1/43 • Number of events 1 • 5 years
|
7.0%
4/57 • Number of events 4 • 5 years
|
0.00%
0/101 • 5 years
|
|
Cardiac disorders
Hypertension
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.7%
2/43 • Number of events 2 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Idiopathic Terminal Ileitis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Hepatobiliary disorders
Increased Liver Function Tests
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Influenza
|
4.7%
2/43 • Number of events 2 • 5 years
|
5.3%
3/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Ingrown toe nail positive for Staphylococcus aureus and beta-hemolytic Strep A
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Interstitial Pneumonitis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Intracranial bleed
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Klebsiella Pneumonia in Urine
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Left Limb Ischemia
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Lesion on lip positive for septate hyphae and dichotomous branching
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Line Infection
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Loss of balance
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Vascular disorders
Lower Extremity Edema
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Mallory Weiss tear
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Metapneumovirus
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma of hard pallate
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Mucomucosis of lungs
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Nausea
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.99%
1/101 • Number of events 1 • 5 years
|
|
Infections and infestations
Necrotizing fasciitis by Clostridium septicum
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
4.7%
2/43 • Number of events 2 • 5 years
|
3.5%
2/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
Occipital hemorrhage
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Skin and subcutaneous tissue disorders
Odynophagiam skin rash
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Oral Graft verses Host Disease
|
4.7%
2/43 • Number of events 2 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Oral Herpes simplex virus
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.3%
1/43 • Number of events 1 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Pain
|
11.6%
5/43 • Number of events 5 • 5 years
|
1.8%
1/57 • Number of events 2 • 5 years
|
0.99%
1/101 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Parainfluenza
|
4.7%
2/43 • Number of events 2 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Surgical and medical procedures
Pericardectomy
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Congenital, familial and genetic disorders
Pericarditis
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Pneumonia
|
18.6%
8/43 • Number of events 12 • 5 years
|
12.3%
7/57 • Number of events 8 • 5 years
|
0.00%
0/101 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonmediastinum
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Positive for Hookworm egg
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Positive Pseudomonas Aeruginosa Blood Cultures
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
PRES
|
0.00%
0/43 • 5 years
|
5.3%
3/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Pseudomonas
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 2 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Refractory Graft verses host disease
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Respiratory syncytial virus
|
9.3%
4/43 • Number of events 4 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Rhinovirus
|
4.7%
2/43 • Number of events 3 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Rigors
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Salmonella Food Poisoning
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/43 • 5 years
|
5.3%
3/57 • Number of events 4 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Sepsis
|
4.7%
2/43 • Number of events 2 • 5 years
|
5.3%
3/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Sinusitis
|
4.7%
2/43 • Number of events 2 • 5 years
|
8.8%
5/57 • Number of events 6 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Skin Abscess
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Small bowell obstruction
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Immune system disorders
Steriod Refractory Gastrointestional Graft verses host disease
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
Stroke
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Nervous system disorders
Subdural hematoma
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • Number of events 1 • 5 years
|
3.5%
2/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia with giant platelets
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
General disorders
Tooth pain
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Toxoplasmosis gondii of the right eye
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Transient Sepsis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Surgical and medical procedures
Transjugular Biopsy
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
|
Gastrointestinal disorders
Typhlitis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Upper Respirtory Infection
|
0.00%
0/43 • 5 years
|
5.3%
3/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
2.3%
1/43 • Number of events 1 • 5 years
|
3.5%
2/57 • Number of events 3 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Viral gastroenteritis
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Viral Infection
|
2.3%
1/43 • Number of events 1 • 5 years
|
0.00%
0/57 • 5 years
|
0.00%
0/101 • 5 years
|
|
Infections and infestations
Wound infection on wrist
|
0.00%
0/43 • 5 years
|
1.8%
1/57 • Number of events 1 • 5 years
|
0.00%
0/101 • 5 years
|
Other adverse events
Adverse event data not reported
Additional Information
Richard Childs, M.D. Principal Investigator, NIH, NHLBI
National Heart Lung and Blood Institute (NHLBI)
Phone: 301.451.7128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place