Trial Outcomes & Findings for Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients (NCT NCT02400255)
NCT ID: NCT02400255
Last Updated: 2023-12-18
Results Overview
Patients who relapsed during or after crenolanib maintenance therapy were categorized as those who received \<28 days of maintenance and those who received \>28 days of maintenance.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years
Results posted on
2023-12-18
Participant Flow
Participant milestones
| Measure |
Patients in Complete Remission 1 (CR1)
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in first complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 2 (CR2)
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in second complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 3 (CR3)
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in third complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Residual Disease
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
5
|
1
|
2
|
|
Overall Study
COMPLETED
|
5
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Patients in Complete Remission 1 (CR1)
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in first complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 2 (CR2)
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in second complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 3 (CR3)
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in third complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Residual Disease
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
|---|---|---|---|---|
|
Overall Study
Relapse
|
4
|
1
|
1
|
2
|
|
Overall Study
Adverse Event
|
6
|
3
|
0
|
0
|
|
Overall Study
Physician Decision
|
6
|
0
|
0
|
0
|
|
Overall Study
Loss of insurance
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
Baseline characteristics by cohort
| Measure |
Patients in Complete Remission 1 (CR1)
n=22 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in first complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 2 (CR2)
n=5 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in second complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 3 (CR3)
n=1 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in third complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Residual Disease
n=2 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=93 Participants
|
53 years
n=4 Participants
|
37 years
n=27 Participants
|
61 years
n=483 Participants
|
53.5 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
FLT3 Mutations
ITD only
|
18 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
FLT3 Mutations
TKD only
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
FLT3 Mutations
ITD and TKD
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
AML diagnosis
De novo AML
|
20 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
|
AML diagnosis
Secondary AML (CMML or MDS)
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Conditioning regimen
Myeloablative
|
16 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Conditioning regimen
Reduced intensity
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Donor type
Matched related
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Donor type
Matched unrelated
|
10 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Donor type
Haploidentical
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPatients who relapsed during or after crenolanib maintenance therapy were categorized as those who received \<28 days of maintenance and those who received \>28 days of maintenance.
Outcome measures
| Measure |
All Subjects
n=30 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while either in first, second or third complete remission with count recovery or with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 1 (CR1)
n=22 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in first complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 2 (CR2)
n=5 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in second complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Patients in Complete Remission 3 (CR3)
n=1 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in third complete remission with count recovery received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
Residual Disease
n=2 Participants
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
|---|---|---|---|---|---|
|
Number of Patients Who Relapsed
Early relapses within the first 28 days of treatment
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients Who Relapsed
Relapses after the first 28 days of treatment
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
All Patients
Serious events: 14 serious events
Other events: 30 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
All Patients
n=30 participants at risk
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while either in first, second or third complete remission with count recovery or with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
General disorders
Pain
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
General disorders
Pyrexia
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Infection
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Lung infection
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
General disorders
Blood creatinine increased
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Investigations
Platelet count decreased
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Nervous system disorders
Presyncope
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Nervous system disorders
Syncope
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Psychiatric disorders
Mental status changes
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Renal and urinary disorders
Haematuria
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
Other adverse events
| Measure |
All Patients
n=30 participants at risk
Subjects who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while either in first, second or third complete remission with count recovery or with incomplete count recovery and bone marrow blasts ≤%10 received crenolanib besylate maintenance therapy. Maintenance was started at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
6/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Eye disorders
Periorbital oedema
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.7%
14/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
18/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Gastrointestinal disorders
Vomiting
|
46.7%
14/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
General disorders
Face oedema
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
General disorders
Fatigue
|
16.7%
5/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
General disorders
Localised oedema
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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|
General disorders
Oedema peripheral
|
16.7%
5/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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General disorders
Pyrexia
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16.7%
5/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Immune system disorders
Graft versus host disease in gastrointestinal tract
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6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Immune system disorders
Graft versus host disease in skin
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10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Herpes zoster
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10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Infection
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
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Infections and infestations
Influenza
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Lung infection
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6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
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Infections and infestations
Pneumonia
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13.3%
4/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Sinusitis
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Staphylococcal infection
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Upper respiratory tract infection
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23.3%
7/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
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Infections and infestations
Urinary tract infection
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Infections and infestations
Urinary tract infection enterococcal
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Investigations
Alanine aminotransferase increased
|
20.0%
6/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Investigations
Aspartate aminotransferase increased
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Investigations
Blood alkaline phosphatase increased
|
13.3%
4/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Investigations
Blood creatinine increased
|
16.7%
5/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Investigations
Neutrophil count decreased
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Investigations
Platelet count decreased
|
40.0%
12/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Metabolism and nutrition disorders
Decreased appetite
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
4/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Nervous system disorders
Dizziness
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Nervous system disorders
Paraesthesia
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Nervous system disorders
Syncope
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Renal and urinary disorders
Acute kidney injury
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Renal and urinary disorders
Haematuria
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
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Skin and subcutaneous tissue disorders
Rash
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
6/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
6.7%
2/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
|
|
Vascular disorders
Hypotension
|
10.0%
3/30 • 2 years
Safety data was presented in a comprehensive manner since no formal arms existed as part of the study; patients were only categorized this way during post-study data analyses to determine if there was a potential relationship between their disease status prior to transplant and their response to maintenance therapy.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place