Trial Outcomes & Findings for Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor (NCT NCT01982682)
NCT ID: NCT01982682
Last Updated: 2025-04-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to 1 year after HSCT
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
CONDITIONING REGIMEN: Patients undergo TBI BID (bis in die/ twice a day) on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo cluster of differentiation 34+ (CD34+) selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
CONDITIONING REGIMEN: Patients undergo TBI BID (bis in die/ twice a day) on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo cluster of differentiation 34+ (CD34+) selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor
Baseline characteristics by cohort
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=41 Participants
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 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
|
4 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
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year after HSCTPopulation: One subject was inevaluable.
Outcome measures
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=40 Participants
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Count of Participants That Experience 1 Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplantation (HSCT) Using the Thomas Jefferson University 2 Step Approach
|
27 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year after HSCTPopulation: One subject was inevaluable
Will be reported descriptively. Successful engraftment is defined as ANC (absolute neutrophil count, the number of white blood cells (WBCs) that are neutrophils) ≥ 0.5x109/L for at least 30 days and Platelet engraftment \> 20,000 with no transfusion x 7 days.
Outcome measures
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=40 Participants
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Number of Participants With Successful Engraftment
|
37 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year after HSCTGraft versus host disease was clinically characterized based on 4 stages of progression for three major body areas, skin, liver, gut. Subjects who experienced life threatening reactions in their skin, liver and gut ultimately experienced functional impairment and expired. Life threatening reactions in the Skin were characterized by desquamation (the shedding of the outer layers of skin) and bullae (a bubblelike cavity filled with air or fluid, in particular). Life threatening reactions in the Liver were characterized by Bilirubin, \> 15 mg/dl Life threatening reactions in the Gut were characterized by Pain +/- ileus (a painful obstruction of the ileum or other part of the intestine.)
Outcome measures
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=40 Participants
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Count of Participants That Experienced Death as a Result of Graft-versus-host Disease (GVHD)
|
2 Participants
|
SECONDARY outcome
Timeframe: At 28 days post HSCTPopulation: 3 subjects were not evaluable for this outcome measure.
An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 28 days will be monitored by collecting cluster of differentiation (CD24) and (CD38).
Outcome measures
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=37 Participants
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Median Pace of T Cell Immune Recovery at 28 Days Post Hematopoietic Stem Cell Transplantation (HSCT)
Median CD3/4 count at d+28
|
41.3 cells/ul
Interval 9.0 to 417.0
|
|
Median Pace of T Cell Immune Recovery at 28 Days Post Hematopoietic Stem Cell Transplantation (HSCT)
Median cluster of diff. 38 (CD3/8) count at d+28
|
48 cells/ul
Interval 7.9 to 1329.0
|
SECONDARY outcome
Timeframe: 90 days post HSCTPopulation: 5 subjects were not evaluable for this outcome measure.
An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 90 days will be monitored by collecting cluster of differentiation (CD24) and (CD38).
Outcome measures
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=35 Participants
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Median Pace of T Cell Immune Recovery at 90 Days Post Hematopoietic Stem Cell Transplantation (HSCT)
Median CD3/4 count at d+90
|
141 cells/ul
Interval 22.0 to 1374.0
|
|
Median Pace of T Cell Immune Recovery at 90 Days Post Hematopoietic Stem Cell Transplantation (HSCT)
Median CD3/8 count at d+90
|
384 cells/ul
Interval 8.4 to 3041.0
|
Adverse Events
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
Serious events: 32 serious events
Other events: 40 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=40 participants at risk
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung Abcess
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Malaise
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Nausea
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
Rhino/enterovirus
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
General disorders
Sleep apnea Desaturation
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Slurred Speech
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Syncope
|
2.5%
1/40 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Upper Extremity Deep Vein Thrombosis
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Eye disorders
Diplopia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
4/40 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Acute Renal Failure
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Altered Mental Status
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Blood in Stool with AVM
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
C. diff infection
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac Disorder
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
CMV reactivation
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
General disorders
Dehydration
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Fall
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
Fever
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Graft rejection
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hematuria
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic failure
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatobiliary issue
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hyperbilirubin
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hypocellular marrow
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Hypovolemia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hypoxia
|
27.5%
11/40 • Number of events 13 • 1 year
|
|
Infections and infestations
Infection
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
Infections and infestations
Klesiella/enterobacteruosepsis with bacteremia
|
2.5%
1/40 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Treatment (TBI, DLI, Cyclophosphamide, CD34+ Donor HSCT)
n=40 participants at risk
CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo CD34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
Total-Body Irradiation (TBI): Undergo TBI
Donor Lymphocyte Infusion (DLI): Undergo DLI
Cyclophosphamide: Given IV
Allogeneic hematopoietic stem cell transplantation (HSCT): Undergo CD34+ selected allogeneic HSCT
Mycophenolate mofetil: Given IV
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.5%
7/40 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Abdominal protuberance
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Aches
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Acid reflux
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
General disorders
Agitated
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Altered Mental state
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Anal fissure
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
22.5%
9/40 • Number of events 9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Ascites
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Cardiac disorders
Asytole
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Infections and infestations
BK virus
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Bladder Spasm
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Blood in stool
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Eye disorders
Blurry vision
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Cardiac disorders
Bradycardia
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
General disorders
Chest pain
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
Infections and infestations
Chest pain (infection)
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
General disorders
Chills
|
20.0%
8/40 • Number of events 8 • 1 year
|
|
Infections and infestations
Clostridium difficile
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Confusion
|
12.5%
5/40 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Nervous system disorders
Cranial nerve deficits
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Cystitis
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Infections and infestations
Cytomegalovirus
|
17.5%
7/40 • Number of events 7 • 1 year
|
|
General disorders
Decreased Appetite
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
General disorders
Decreased Ejection fraction
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Decreased intake
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Decreased Urine Output
|
17.5%
7/40 • Number of events 8 • 1 year
|
|
General disorders
Dehydration
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
85.0%
34/40 • Number of events 35 • 1 year
|
|
General disorders
Dizziness
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
Eye disorders
Double vision
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Eye disorders
Dry eyes
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
General disorders
Dry Mouth
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
General disorders
Edema
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
General disorders
Electrolyte imbalance
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Elevated glucose
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Emesis
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Epistaxis
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythemia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Fall
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Infections and infestations
Fever
|
90.0%
36/40 • Number of events 43 • 1 year
|
|
Gastrointestinal disorders
Flatus
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Fluid Overload
|
30.0%
12/40 • Number of events 12 • 1 year
|
|
General disorders
General pain
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Hallucinations
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
General disorders
Headache
|
25.0%
10/40 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Heartburn
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
Hepatobiliary disorders
Hepatic Failure
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
HHV6 reactivation
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
25.0%
10/40 • Number of events 10 • 1 year
|
|
Blood and lymphatic system disorders
Hypertension
|
20.0%
8/40 • Number of events 8 • 1 year
|
|
Blood and lymphatic system disorders
Hypokalemia
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hypotension
|
20.0%
8/40 • Number of events 9 • 1 year
|
|
General disorders
Hypoxia
|
17.5%
7/40 • Number of events 7 • 1 year
|
|
Blood and lymphatic system disorders
Increased Creatine
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Hepatobiliary disorders
Increased LFTs
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Indigestion
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Product Issues
infusion reaction
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Insomnia
|
20.0%
8/40 • Number of events 8 • 1 year
|
|
Immune system disorders
Intravenous immune globulin reaction
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Itching
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
General disorders
Lethargy
|
22.5%
9/40 • Number of events 9 • 1 year
|
|
Hepatobiliary disorders
LFT abnormality
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
General disorders
Lightheadedness
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Loose stools
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Weakness
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Mucositis
|
95.0%
38/40 • Number of events 38 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle pains
|
25.0%
10/40 • Number of events 15 • 1 year
|
|
General disorders
Nausea
|
32.5%
13/40 • Number of events 13 • 1 year
|
|
Nervous system disorders
Neuropathy
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
Infections and infestations
Neutropenic fever
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Orthostasis
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Panic attack
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Nervous system disorders
Paresthesia
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
Infections and infestations
Parotitis
|
15.0%
6/40 • Number of events 6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Peeling skin
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Cardiac disorders
Pericardial Effusion
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Pericatheter Thrombus
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Perineal pain
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Pharyngeal edema
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Eye disorders
Photophobia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Platelet Transfusion Reaction
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritis rash
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Infections and infestations
Pseudomonas bacteremia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
55.0%
22/40 • Number of events 23 • 1 year
|
|
Gastrointestinal disorders
Rectal pain
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinoenterovirus
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Rigors
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Reproductive system and breast disorders
Scrotal swelling
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Sinus pain
|
7.5%
3/40 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin breakdown
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Splenomegaly
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Sweats
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Swelling
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Syncopal episode
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Cardiac disorders
Tachycardia
|
25.0%
10/40 • Number of events 11 • 1 year
|
|
Reproductive system and breast disorders
Testicular pain
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Infections and infestations
Thrush
|
5.0%
2/40 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Tremor
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Trouble breathing
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Trouble sleeping
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
5/40 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Urinary Retention
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary Urgency
|
2.5%
1/40 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
UTI
|
10.0%
4/40 • Number of events 4 • 1 year
|
|
Cardiac disorders
Ventricular tachychardia
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Eye disorders
Visual Disturbance
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
General disorders
Volume overload
|
2.5%
1/40 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
9/40 • Number of events 9 • 1 year
|
|
General disorders
Weakness
|
12.5%
5/40 • Number of events 5 • 1 year
|
Additional Information
Dr. Dolores Grosso
Sidney Kimmel Cancer Center at Thomas Jefferson University
Phone: 215-955-0182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place