Trial Outcomes & Findings for Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) (NCT NCT03150004)
NCT ID: NCT03150004
Last Updated: 2026-03-30
Results Overview
The number of participants who achieve MRD CR (see Cheson 2003, Cheson 2006 in the references below).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Day 35
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
CLAG-M Regimen
Subject's treatment cycle is 30 days.
Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen: Subjects will be started on CLAG-M regimen, which consists of the following:
* Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
* Cytarabine 2 gm/m\^2 IV over four hours on days 1-5
* Mitoxantrone 10 mg/m\^2 IV on days 1-3;
* G-CSF at a dose of 300 μg on days 0-5.
|
CLLDAC Regimen
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
13
|
|
Overall Study
COMPLETED
|
40
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
CLAG-M Regimen
n=40 Participants
Subject's treatment cycle is 30 days.
Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen: Subjects will be started on CLAG-M regimen, which consists of the following:
* Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
* Cytarabine 2 gm/m\^2 IV over four hours on days 1-5
* Mitoxantrone 10 mg/m\^2 IV on days 1-3;
* G-CSF at a dose of 300 μg on days 0-5.
|
CLLDAC Regimen
n=13 Participants
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=4 Participants
|
2 Participants
n=28 Participants
|
31 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=4 Participants
|
11 Participants
n=28 Participants
|
22 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=4 Participants
|
6 Participants
n=28 Participants
|
23 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=4 Participants
|
13 Participants
n=28 Participants
|
51 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=4 Participants
|
13 Participants
n=28 Participants
|
48 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=4 Participants
|
13 participants
n=28 Participants
|
53 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 35The number of participants who achieve MRD CR (see Cheson 2003, Cheson 2006 in the references below).
Outcome measures
| Measure |
CLAG-M Arm
n=40 Participants
Subject's treatment cycle is 30 days.
|
CLLDAC Regimen
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
CLAG-M Arm: Minimal Residual Disease (MRD) Complete Remission (CR)
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 35The number of participants who achieve MRD CR following one cycle of therapy (see Cheson 2003, Cheson 2006 in the references below).
Outcome measures
| Measure |
CLAG-M Arm
n=13 Participants
Subject's treatment cycle is 30 days.
|
CLLDAC Regimen
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
CLLDAC Arm: Minimal Residual Disease (MRD) Complete Remission (CR)
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 70The number of subjects who require a second cycle of CLLDAC.
Outcome measures
| Measure |
CLAG-M Arm
n=13 Participants
Subject's treatment cycle is 30 days.
|
CLLDAC Regimen
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
CLLDAC Arm: Subjects Receiving a Second Cycle.
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 4 YearsDuration of OS: Time from treatment initiation through death from any cause, up to 4 years
Outcome measures
| Measure |
CLAG-M Arm
n=40 Participants
Subject's treatment cycle is 30 days.
|
CLLDAC Regimen
n=13 Participants
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
Overall Survival (OS)
|
28.3 percentage of patients
Interval 15.2 to 42.9
|
0 percentage of patients
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Year 4Population: Note that PFS is reported only among patients with remission, but nobody in arm B (CLLDAC) had a remission, so PFS is not applicable.
Duration of PFS: Time from remission (date of bone marrow biopsy confirming CR/CRi) to relapse or death from any cause, whichever occurs first, up to 4 years
Outcome measures
| Measure |
CLAG-M Arm
n=18 Participants
Subject's treatment cycle is 30 days.
|
CLLDAC Regimen
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
Progression-free Survival
|
55.6 percentage of patients with remission
Interval 30.5 to 74.8
|
—
|
Adverse Events
CLAG-M Regimen
Serious events: 8 serious events
Other events: 40 other events
Deaths: 32 deaths
CLLDAC Regimen
Serious events: 8 serious events
Other events: 13 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
CLAG-M Regimen
n=40 participants at risk
Subject's treatment cycle is 30 days.
Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen: Subjects will be started on CLAG-M regimen, which consists of the following:
* Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
* Cytarabine 2 gm/m\^2 IV over four hours on days 1-5
* Mitoxantrone 10 mg/m\^2 IV on days 1-3;
* G-CSF at a dose of 300 μg on days 0-5.
|
CLLDAC Regimen
n=13 participants at risk
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
Nervous system disorders
Encephalopathy
|
2.5%
1/40 • Number of events 1 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
3/40 • Number of events 3 • Up to 4 years.
|
46.2%
6/13 • Number of events 6 • Up to 4 years.
|
|
General disorders
Multiorgan Failure
|
2.5%
1/40 • Number of events 1 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Infections and infestations
Sepsis
|
5.0%
2/40 • Number of events 2 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.5%
1/40 • Number of events 1 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Infections and infestations
Lung infection
|
0.00%
0/40 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
General disorders
Fever
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
Other adverse events
| Measure |
CLAG-M Regimen
n=40 participants at risk
Subject's treatment cycle is 30 days.
Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen: Subjects will be started on CLAG-M regimen, which consists of the following:
* Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
* Cytarabine 2 gm/m\^2 IV over four hours on days 1-5
* Mitoxantrone 10 mg/m\^2 IV on days 1-3;
* G-CSF at a dose of 300 μg on days 0-5.
|
CLLDAC Regimen
n=13 participants at risk
Subject's treatment cycle is 30 days. Subject may be treated on an outpatient basis (CLLDAC arm only). In addition, subjects who fail to achieve a CR/CRi after the first 30-day cycle may receive a second cycle of CLLDAC, per the discretion of the treating physician. Subjects who receive this second cycle should begin cycle 2 no later than 49 days after cycle 1.
Cladribine and Cytarabine (CLLDAC) Regimen: - Cladribine 5 mg/m\^2 IV over two hours on days 1-5;
\- Cytarabine 20 mg/m\^2 subcutaneous injection on days 1-10;
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
62.5%
25/40 • Number of events 53 • Up to 4 years.
|
23.1%
3/13 • Number of events 4 • Up to 4 years.
|
|
General disorders
Non-cardiac chest pain
|
17.5%
7/40 • Number of events 7 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
10/40 • Number of events 11 • Up to 4 years.
|
15.4%
2/13 • Number of events 4 • Up to 4 years.
|
|
Gastrointestinal disorders
Bloating
|
22.5%
9/40 • Number of events 11 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Investigations
Blood bilirubin increased
|
22.5%
9/40 • Number of events 17 • Up to 4 years.
|
38.5%
5/13 • Number of events 11 • Up to 4 years.
|
|
Eye disorders
Blurred vision
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.5%
3/40 • Number of events 3 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
38.5%
5/13 • Number of events 6 • Up to 4 years.
|
|
General disorders
Chills
|
32.5%
13/40 • Number of events 15 • Up to 4 years.
|
23.1%
3/13 • Number of events 3 • Up to 4 years.
|
|
Gastrointestinal disorders
Colitis
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
15/40 • Number of events 17 • Up to 4 years.
|
53.8%
7/13 • Number of events 9 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Number of events 9 • Up to 4 years.
|
38.5%
5/13 • Number of events 6 • Up to 4 years.
|
|
Investigations
Creatinine increased
|
15.0%
6/40 • Number of events 12 • Up to 4 years.
|
30.8%
4/13 • Number of events 7 • Up to 4 years.
|
|
Psychiatric disorders
Depression
|
10.0%
4/40 • Number of events 4 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Gastrointestinal disorders
Diarrhea
|
65.0%
26/40 • Number of events 31 • Up to 4 years.
|
30.8%
4/13 • Number of events 7 • Up to 4 years.
|
|
Nervous system disorders
Dizziness
|
35.0%
14/40 • Number of events 17 • Up to 4 years.
|
46.2%
6/13 • Number of events 6 • Up to 4 years.
|
|
Eye disorders
Dry eye
|
22.5%
9/40 • Number of events 14 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.5%
9/40 • Number of events 9 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Nervous system disorders
Dysgeusia
|
17.5%
7/40 • Number of events 7 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
5/40 • Number of events 6 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
12/40 • Number of events 14 • Up to 4 years.
|
53.8%
7/13 • Number of events 11 • Up to 4 years.
|
|
General disorders
Edema limbs
|
45.0%
18/40 • Number of events 23 • Up to 4 years.
|
38.5%
5/13 • Number of events 8 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.5%
7/40 • Number of events 10 • Up to 4 years.
|
23.1%
3/13 • Number of events 3 • Up to 4 years.
|
|
Eye disorders
Eye pain
|
15.0%
6/40 • Number of events 6 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
General disorders
Fatigue
|
60.0%
24/40 • Number of events 30 • Up to 4 years.
|
61.5%
8/13 • Number of events 12 • Up to 4 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
47.5%
19/40 • Number of events 26 • Up to 4 years.
|
38.5%
5/13 • Number of events 7 • Up to 4 years.
|
|
General disorders
Fever
|
45.0%
18/40 • Number of events 32 • Up to 4 years.
|
53.8%
7/13 • Number of events 14 • Up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
25.0%
10/40 • Number of events 14 • Up to 4 years.
|
46.2%
6/13 • Number of events 7 • Up to 4 years.
|
|
Nervous system disorders
Headache
|
47.5%
19/40 • Number of events 31 • Up to 4 years.
|
38.5%
5/13 • Number of events 7 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
82.5%
33/40 • Number of events 90 • Up to 4 years.
|
23.1%
3/13 • Number of events 13 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
17.5%
7/40 • Number of events 8 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
15.0%
6/40 • Number of events 8 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Vascular disorders
Hypertension
|
65.0%
26/40 • Number of events 106 • Up to 4 years.
|
46.2%
6/13 • Number of events 23 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.0%
32/40 • Number of events 59 • Up to 4 years.
|
76.9%
10/13 • Number of events 24 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
80.0%
32/40 • Number of events 112 • Up to 4 years.
|
69.2%
9/13 • Number of events 33 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
20/40 • Number of events 57 • Up to 4 years.
|
46.2%
6/13 • Number of events 28 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
30.8%
4/13 • Number of events 8 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
65.0%
26/40 • Number of events 56 • Up to 4 years.
|
46.2%
6/13 • Number of events 22 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
32.5%
13/40 • Number of events 35 • Up to 4 years.
|
53.8%
7/13 • Number of events 14 • Up to 4 years.
|
|
Vascular disorders
Hypotension
|
52.5%
21/40 • Number of events 27 • Up to 4 years.
|
46.2%
6/13 • Number of events 15 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
6/40 • Number of events 6 • Up to 4 years.
|
15.4%
2/13 • Number of events 3 • Up to 4 years.
|
|
General disorders
Infusion related reaction
|
17.5%
7/40 • Number of events 7 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Psychiatric disorders
Insomnia
|
37.5%
15/40 • Number of events 17 • Up to 4 years.
|
30.8%
4/13 • Number of events 4 • Up to 4 years.
|
|
Investigations
Lymphocyte count decreased
|
92.5%
37/40 • Number of events 107 • Up to 4 years.
|
100.0%
13/13 • Number of events 46 • Up to 4 years.
|
|
General disorders
Malaise
|
12.5%
5/40 • Number of events 6 • Up to 4 years.
|
15.4%
2/13 • Number of events 3 • Up to 4 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
30.0%
12/40 • Number of events 17 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
20/40 • Number of events 24 • Up to 4 years.
|
53.8%
7/13 • Number of events 10 • Up to 4 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
15/40 • Number of events 16 • Up to 4 years.
|
30.8%
4/13 • Number of events 4 • Up to 4 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
4/40 • Number of events 4 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
16/40 • Number of events 34 • Up to 4 years.
|
38.5%
5/13 • Number of events 8 • Up to 4 years.
|
|
Investigations
Alkaline phosphatase increased
|
32.5%
13/40 • Number of events 18 • Up to 4 years.
|
30.8%
4/13 • Number of events 5 • Up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.5%
7/40 • Number of events 7 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Blood and lymphatic system disorders
Anemia
|
67.5%
27/40 • Number of events 106 • Up to 4 years.
|
23.1%
3/13 • Number of events 24 • Up to 4 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.0%
18/40 • Number of events 24 • Up to 4 years.
|
23.1%
3/13 • Number of events 6 • Up to 4 years.
|
|
Psychiatric disorders
Anxiety
|
20.0%
8/40 • Number of events 8 • Up to 4 years.
|
23.1%
3/13 • Number of events 3 • Up to 4 years.
|
|
Investigations
Aspartate aminotransferase increased
|
45.0%
18/40 • Number of events 39 • Up to 4 years.
|
30.8%
4/13 • Number of events 6 • Up to 4 years.
|
|
General disorders
Pain
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.5%
9/40 • Number of events 15 • Up to 4 years.
|
30.8%
4/13 • Number of events 5 • Up to 4 years.
|
|
Nervous system disorders
Paresthesia
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.0%
6/40 • Number of events 6 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Investigations
Platelet count decreased
|
67.5%
27/40 • Number of events 148 • Up to 4 years.
|
15.4%
2/13 • Number of events 9 • Up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
6/40 • Number of events 6 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
5/40 • Number of events 6 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
5/40 • Number of events 10 • Up to 4 years.
|
0.00%
0/13 • Up to 4 years.
|
|
Infections and infestations
Sepsis
|
12.5%
5/40 • Number of events 6 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Cardiac disorders
Sinus bradycardia
|
22.5%
9/40 • Number of events 20 • Up to 4 years.
|
23.1%
3/13 • Number of events 13 • Up to 4 years.
|
|
Cardiac disorders
Sinus tachycardia
|
35.0%
14/40 • Number of events 18 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
8/40 • Number of events 8 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
15.4%
2/13 • Number of events 2 • Up to 4 years.
|
|
Investigations
Weight gain
|
15.0%
6/40 • Number of events 7 • Up to 4 years.
|
15.4%
2/13 • Number of events 4 • Up to 4 years.
|
|
Investigations
Weight loss
|
12.5%
5/40 • Number of events 5 • Up to 4 years.
|
7.7%
1/13 • Number of events 1 • Up to 4 years.
|
|
Investigations
White blood cell decreased
|
72.5%
29/40 • Number of events 67 • Up to 4 years.
|
76.9%
10/13 • Number of events 21 • Up to 4 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place