Trial Outcomes & Findings for Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases (NCT NCT02248597)
NCT ID: NCT02248597
Last Updated: 2023-10-11
Results Overview
The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
At 12 months
Results posted on
2023-10-11
Participant Flow
Participant milestones
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
Baseline characteristics by cohort
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 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
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 monthsThe percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
12 Month Disease Free Survival Probability
|
51.8 percentage of participants
Interval 33.0 to 70.7
|
SECONDARY outcome
Timeframe: 12 monthsKaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Rate of Acute GvHD
|
51.8 percentage of participants
Interval 30.0 to 70.7
|
SECONDARY outcome
Timeframe: At 12 monthsThe survival function will be estimated and plotted using the method of Kaplan and Meier.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Overall Survival
|
66.7 percentage of participants
Interval 45.7 to 81.1
|
SECONDARY outcome
Timeframe: At 12 monthsKaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Progression Free Survival
|
51.8 percentage of participants
Interval 31.9 to 68.5
|
SECONDARY outcome
Timeframe: At 12 monthsNon-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk.
Outcome measures
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 Participants
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Relapse-free Mortality
|
86.8 days
Interval 63.4 to 95.7
|
Adverse Events
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
Serious events: 27 serious events
Other events: 27 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 participants at risk
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
General disorders
Death
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
29.6%
8/27 • Number of events 8 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Lymphocyte count decreased
|
74.1%
20/27 • Number of events 20 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Neutrophil count decreased
|
55.6%
15/27 • Number of events 15 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Platelet count decreased
|
85.2%
23/27 • Number of events 23 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
White blood cell count decreased
|
88.9%
24/27 • Number of events 24 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Eye disorders
Retinal vascular disorder
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Fever
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Ongoing viremia
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Stenotrophomonas
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Kidney infection
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Lung infection
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Sepsis
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Skin infection
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Chronic kidney disease
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Hematuria
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Renal hemorrhage
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Lymphedema
|
3.7%
1/27 • Number of events 1 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
Other adverse events
| Measure |
Treatment (Stem Cell Transplant With GVHD Prophylaxis)
n=27 participants at risk
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV QD on days -6 to -2. Patients receiving myeloablative conditioning receive busulfan IV every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan IV every 6 hours for 8 doses on days -5 to -4. Patients also receive cyclophosphamide IV QD on days -3 and -2
TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide QD on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. Allogeneic hematopoietic stem cell transplantation
fludarabine phosphate: Given IV
busulfan: Given IV
cyclophosphamide: Given IV
allogeneic hematopoietic stem cell transplantation: Undergo myeloablative or reduced intensity allogeneic stem cell transplant
tacrolimus
mycophenolate mofetil
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.9%
24/27 • Number of events 24 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
ALC decrease
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
22.2%
6/27 • Number of events 6 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Alanine aminotransferase increased
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Alkaline phosphatase increased
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Bilirubin increased
|
33.3%
9/27 • Number of events 9 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Cardiac troponin I increased
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Creatinine increased
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Lymphocyte count decreased
|
59.3%
16/27 • Number of events 16 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Neutrophil count decreased
|
48.1%
13/27 • Number of events 13 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Platelet count decreased
|
70.4%
19/27 • Number of events 19 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
White blood cell count decreased
|
63.0%
17/27 • Number of events 17 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Cardiac disorders
Hypervolemia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Cardiac disorders
Heart failure
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Cardiac disorders
Palpitations
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Cardiac disorders
Periocardial effusions
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Cardiac disorders
Sinus bradycardia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Cardiac disorders
Sinus tachycardia
|
51.9%
14/27 • Number of events 14 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Fatigue
|
81.5%
22/27 • Number of events 22 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Eye disorders
Dry eye
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
44.4%
12/27 • Number of events 12 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Anal pain
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Ascites
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Bloating
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Constipation
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
21/27 • Number of events 21 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Dry mouth
|
37.0%
10/27 • Number of events 10 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Dysphagia
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Esophagitis
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Oral mucositis
|
40.7%
11/27 • Number of events 11 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Nausea
|
77.8%
21/27 • Number of events 21 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Oral pain
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Dysgeusia
|
40.7%
11/27 • Number of events 11 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
40.7%
11/27 • Number of events 11 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Chills
|
48.1%
13/27 • Number of events 13 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Edema, face
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Edema, limbs
|
51.9%
14/27 • Number of events 14 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Gait disturbance
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Hypothermia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Infusion related reaction
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Localized edema
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Malaise
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Non-cardiac chest pain
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Pain
|
29.6%
8/27 • Number of events 8 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Immune system disorders
Cytokine release syndrome
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Catheter related infection
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
BK viruria urine
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
CMV Miremia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Lung infection
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Mucosal infection
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Papulopustular rash
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Skin infection
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Infections and infestations
Urinary tract infection
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
22.2%
6/27 • Number of events 6 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Weight gain
|
29.6%
8/27 • Number of events 8 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Investigations
Weight loss
|
33.3%
9/27 • Number of events 9 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Alkalosis
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Anorexia
|
55.6%
15/27 • Number of events 15 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
59.3%
16/27 • Number of events 16 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
55.6%
15/27 • Number of events 15 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.4%
12/27 • Number of events 12 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
55.6%
15/27 • Number of events 15 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
59.3%
16/27 • Number of events 16 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
51.9%
14/27 • Number of events 14 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
22.2%
6/27 • Number of events 6 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Metabolism and nutrition disorders
Malnutrition
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
37.0%
10/27 • Number of events 10 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
44.4%
12/27 • Number of events 12 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
37.0%
10/27 • Number of events 10 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Dizziness
|
33.3%
9/27 • Number of events 9 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Encephalopathy
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Headache
|
59.3%
16/27 • Number of events 16 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Lethargy
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Presyncope
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Somnolence
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Nervous system disorders
Tremor
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Psychiatric disorders
Anxiety
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Psychiatric disorders
Confusion
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Psychiatric disorders
Depression
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Psychiatric disorders
Insomnia
|
22.2%
6/27 • Number of events 6 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Bladder spasm
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Proteinuria
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Urinary frequency
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Urinary retention
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Urinary tract pain
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Urinary urgency
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Reproductive system and breast disorders
Scrotal pain
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
51.9%
14/27 • Number of events 14 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.2%
6/27 • Number of events 6 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
44.4%
12/27 • Number of events 12 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
29.6%
8/27 • Number of events 8 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
44.4%
12/27 • Number of events 12 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
SKin hyperpigmentation
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
18.5%
5/27 • Number of events 5 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Flushing
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Hematoma
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Hot flashes
|
14.8%
4/27 • Number of events 4 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Hypertension
|
33.3%
9/27 • Number of events 9 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Vascular disorders
Hypotension
|
37.0%
10/27 • Number of events 10 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.7%
11/27 • Number of events 11 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
General disorders
Fever
|
66.7%
18/27 • Number of events 18 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
22.2%
6/27 • Number of events 6 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Chronic kidney disease
|
29.6%
8/27 • Number of events 8 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Renal and urinary disorders
Hematuria
|
25.9%
7/27 • Number of events 7 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
3/27 • Number of events 3 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.4%
2/27 • Number of events 2 • Adverse events were monitored 100 days post-transplant. Deaths were assessed for 1 year.
|
Additional Information
Study Nurse
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-4761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place