Trial Outcomes & Findings for Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning (NCT NCT01572662)
NCT ID: NCT01572662
Last Updated: 2023-06-29
Results Overview
Number of participants expired within the first 100 days after transplant not due to relapsed disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
100 days
Results posted on
2023-06-29
Participant Flow
Participants were recruited from April 2012 to December 2015 at MD Anderson Cancer Center.
Participant milestones
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
151
|
|
Overall Study
COMPLETED
|
49
|
150
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning
Baseline characteristics by cohort
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
n=49 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
n=150 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
149 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 daysNumber of participants expired within the first 100 days after transplant not due to relapsed disease.
Outcome measures
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
n=49 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
n=150 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Non-Relapse Mortality Rate (NRM)
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year post-transplantNumber of participants that are disease free and alive one year post transplant.
Outcome measures
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
n=49 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
n=150 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Overall Survival
|
29 Participants
|
93 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years post-transplantNumber of participants that were diseased free and alive 3 years post-transplant.
Outcome measures
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
n=49 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
n=150 Participants
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Overall Survival
|
16 Participants
|
47 Participants
|
Adverse Events
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
Serious events: 6 serious events
Other events: 43 other events
Deaths: 31 deaths
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
Serious events: 8 serious events
Other events: 141 other events
Deaths: 93 deaths
Serious adverse events
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
n=49 participants at risk
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
n=150 participants at risk
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin GvHD
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
4.0%
6/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Bacterial Infections
|
12.2%
6/49 • Adverse events were collected up to 3 years post transplant.
|
5.3%
8/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Viral Infections
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
2.7%
4/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
4.0%
6/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Blood and lymphatic system disorders
Transcient Secondary graft failure
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
2.0%
3/150 • Adverse events were collected up to 3 years post transplant.
|
|
Blood and lymphatic system disorders
Delayed engraftment
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Blood and lymphatic system disorders
Primary graft failure
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Blood and lymphatic system disorders
ABO incompatibility
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Low Platelet
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
GI GvHD
|
12.2%
6/49 • Adverse events were collected up to 3 years post transplant.
|
3.3%
5/150 • Adverse events were collected up to 3 years post transplant.
|
|
Hepatobiliary disorders
Liver GvHD
|
6.1%
3/49 • Adverse events were collected up to 3 years post transplant.
|
3.3%
5/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Fungal Infections
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Parasite Infections
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
General disorders
Sepsis like syndrome
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Blood and lymphatic system disorders
HSCT related microangiopathy (TA-TMA)
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Oral mucositis
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Musculoskeletal and connective tissue disorders
Polyneuropathy
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Hepatobiliary disorders
Elevated bilirubin
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Hepatobiliary disorders
VOD/SOS
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
2.0%
3/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic lung GvHD
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Diverticulitis/neutropenic colitis
|
0.00%
0/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Immune system disorders
Autoimmune hemolytic anemia
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
Other adverse events
| Measure |
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
n=49 participants at risk
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
|
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
n=150 participants at risk
Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed sequential Busulfan AUC 16,000umol/l vs. Fludarabine/Timed Sequential (TS) Busulfan AUC 20,000umol/l.
|
|---|---|---|
|
Infections and infestations
Bacterial Infections
|
44.9%
22/49 • Adverse events were collected up to 3 years post transplant.
|
54.7%
82/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Parasite Infections
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Fungal Infections
|
6.1%
3/49 • Adverse events were collected up to 3 years post transplant.
|
5.3%
8/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
Viral Infections
|
46.9%
23/49 • Adverse events were collected up to 3 years post transplant.
|
50.0%
75/150 • Adverse events were collected up to 3 years post transplant.
|
|
General disorders
Fevers
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
2.7%
4/150 • Adverse events were collected up to 3 years post transplant.
|
|
General disorders
Flu like syndrome
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
General disorders
Fluid overload
|
51.0%
25/49 • Adverse events were collected up to 3 years post transplant.
|
54.0%
81/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
ABO incompatibility
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
GI GvHD
|
18.4%
9/49 • Adverse events were collected up to 3 years post transplant.
|
24.7%
37/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Liver GvGHD
|
20.4%
10/49 • Adverse events were collected up to 3 years post transplant.
|
25.3%
38/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Mucositis
|
75.5%
37/49 • Adverse events were collected up to 3 years post transplant.
|
94.0%
141/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Upper GI GvHD
|
22.4%
11/49 • Adverse events were collected up to 3 years post transplant.
|
22.7%
34/150 • Adverse events were collected up to 3 years post transplant.
|
|
Hepatobiliary disorders
Liver GvHD
|
12.2%
6/49 • Adverse events were collected up to 3 years post transplant.
|
25.3%
38/150 • Adverse events were collected up to 3 years post transplant.
|
|
Metabolism and nutrition disorders
Chronic GI GvHD
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Eye disorders
Chronic ocular GvHD
|
20.4%
10/49 • Adverse events were collected up to 3 years post transplant.
|
16.7%
25/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Chronic oral GvHD
|
10.2%
5/49 • Adverse events were collected up to 3 years post transplant.
|
16.7%
25/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic lung GvGHD
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
6.0%
9/150 • Adverse events were collected up to 3 years post transplant.
|
|
Blood and lymphatic system disorders
Neutropenic fevers
|
16.3%
8/49 • Adverse events were collected up to 3 years post transplant.
|
27.3%
41/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
7/49 • Adverse events were collected up to 3 years post transplant.
|
18.7%
28/150 • Adverse events were collected up to 3 years post transplant.
|
|
Skin and subcutaneous tissue disorders
Skin GvHD
|
59.2%
29/49 • Adverse events were collected up to 3 years post transplant.
|
0.00%
0/150 • Adverse events were collected up to 3 years post transplant.
|
|
Vascular disorders
Hypertension
|
22.4%
11/49 • Adverse events were collected up to 3 years post transplant.
|
34.0%
51/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
7/49 • Adverse events were collected up to 3 years post transplant.
|
20.0%
30/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Nausea
|
87.8%
43/49 • Adverse events were collected up to 3 years post transplant.
|
79.3%
119/150 • Adverse events were collected up to 3 years post transplant.
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Infections and infestations
BK virus assoiated Hemorrhagic cystitis
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
13.3%
20/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Elevated transminitis
|
44.9%
22/49 • Adverse events were collected up to 3 years post transplant.
|
28.0%
42/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Elevated bilirubin
|
32.7%
16/49 • Adverse events were collected up to 3 years post transplant.
|
38.0%
57/150 • Adverse events were collected up to 3 years post transplant.
|
|
Psychiatric disorders
Encephalopathy
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
12.7%
19/150 • Adverse events were collected up to 3 years post transplant.
|
|
Cardiac disorders
Ejection fraction decreased
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
2.7%
4/150 • Adverse events were collected up to 3 years post transplant.
|
|
Renal and urinary disorders
Renal insufficiency
|
51.0%
25/49 • Adverse events were collected up to 3 years post transplant.
|
16.7%
25/150 • Adverse events were collected up to 3 years post transplant.
|
|
Skin and subcutaneous tissue disorders
Chronic Skin GvHD
|
6.1%
3/49 • Adverse events were collected up to 3 years post transplant.
|
2.0%
3/150 • Adverse events were collected up to 3 years post transplant.
|
|
Musculoskeletal and connective tissue disorders
Chronic GvHD
|
6.1%
3/49 • Adverse events were collected up to 3 years post transplant.
|
2.0%
3/150 • Adverse events were collected up to 3 years post transplant.
|
|
Reproductive system and breast disorders
Chronic vaginal GvHD
|
6.1%
3/49 • Adverse events were collected up to 3 years post transplant.
|
2.0%
3/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic GvHD_Serositis
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
BOOP
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Cardiac disorders
Dysrhythmia
|
10.2%
5/49 • Adverse events were collected up to 3 years post transplant.
|
3.3%
5/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Gastrointestinal disorders
Diverticulits/colitis
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Nervous system disorders
PRES
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
2.7%
4/150 • Adverse events were collected up to 3 years post transplant.
|
|
Psychiatric disorders
Confusions
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Psychiatric disorders
Hallucination
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • Adverse events were collected up to 3 years post transplant.
|
3.3%
5/150 • Adverse events were collected up to 3 years post transplant.
|
|
Nervous system disorders
Tremor
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Hepatobiliary disorders
VOD/SOS
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Autoimmune hemolytic anemia
|
8.2%
4/49 • Adverse events were collected up to 3 years post transplant.
|
2.7%
4/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Red cell dysplasia due to major ABO incompatibility
|
6.1%
3/49 • Adverse events were collected up to 3 years post transplant.
|
2.0%
3/150 • Adverse events were collected up to 3 years post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.1%
2/49 • Adverse events were collected up to 3 years post transplant.
|
1.3%
2/150 • Adverse events were collected up to 3 years post transplant.
|
|
Vascular disorders
Thromboembolic event
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
|
Investigations
Idiopathic thrombocytopenic purpura (ITP)
|
2.0%
1/49 • Adverse events were collected up to 3 years post transplant.
|
0.67%
1/150 • Adverse events were collected up to 3 years post transplant.
|
Additional Information
Uday Popat, M.D. / Stem Cell Transplantation
The University of Texas MD Anderson Cancer Center
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place