Trial Outcomes & Findings for A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (NCT NCT03992339)
NCT ID: NCT03992339
Last Updated: 2025-02-07
Results Overview
ORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
12 months
Results posted on
2025-02-07
Participant Flow
Participant milestones
| Measure |
ATG-010
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
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|---|---|
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Overall Study
STARTED
|
60
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Overall Study
COMPLETED
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60
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
ATG-010
n=60 Participants
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
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|---|---|
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Age, Continuous
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58.8 years
STANDARD_DEVIATION 11.36 • n=5 Participants
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Sex: Female, Male
Female
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27 Participants
n=5 Participants
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Sex: Female, Male
Male
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33 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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60 Participants
n=5 Participants
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Body Mass Index (BMI)
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23.94 kg/m^2
STANDARD_DEVIATION 3.089 • n=5 Participants
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PRIMARY outcome
Timeframe: 12 monthsORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.)
Outcome measures
| Measure |
ATG-010
n=60 Participants
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
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|---|---|
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ORR
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13 Participants
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SECONDARY outcome
Timeframe: 12 monthsPFS is defined as the duration from start of selinexor treatment to time of central imaging laboratory determined PD (based on 2014 Lugano criteria: Progressive metabolic disease requires Score 4 or 5 with an increase in intensity of uptake from baseline. Progressive disease by CT criteria only requires an increase in the PPDs of a single node by ≥ 50%.)or death from any cause, whichever occurs first.
Outcome measures
| Measure |
ATG-010
n=60 Participants
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
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|---|---|
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PFS
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1.87 month
Interval 1.81 to 2.1
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Adverse Events
ATG-010
Serious events: 24 serious events
Other events: 60 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
ATG-010
n=60 participants at risk
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
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|---|---|
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Investigations
Platelet count dicreased
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15.0%
9/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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|
Investigations
Neutrophil count decreased
|
5.0%
3/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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|
Investigations
White blood cell count decreased
|
3.3%
2/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Gastrointestinal disorders
Dysphagia
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Gastrointestinal disorders
Nausea
|
1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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|
Gastrointestinal disorders
Gastritis
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Gastrointestinal disorders
Ascites
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
|
Gastrointestinal disorders
Abdominal pain
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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General disorders
Pyrexia
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3.3%
2/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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General disorders
Adynamia
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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General disorders
Multiple organ dysfunction syndrome
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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General disorders
Cause Death
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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General disorders
Pain
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Infections and infestations
COVID-19 pneumonia
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Infections and infestations
Pneumonia
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Metabolism and nutrition disorders
Decreased appetite
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Nervous system disorders
Spinal cord compression
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Eye disorders
Cataract
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Renal and urinary disorders
Acute kidney injury
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Blood and lymphatic system disorders
Anaemia
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1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Vascular disorders
Venous thrombosis
|
1.7%
1/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Other adverse events
| Measure |
ATG-010
n=60 participants at risk
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle: Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
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|---|---|
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Investigations
Platelet count decreased
|
98.3%
59/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
|
Investigations
White blood cell count decreased
|
81.7%
49/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Neutrophil count decreased
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80.0%
48/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Weight decreased
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38.3%
23/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Lymphocyte count decreased
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30.0%
18/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Aspartate aminotransferase increased
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20.0%
12/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Alanine aminotransferase increased
|
16.7%
10/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Blood creatinine increased
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16.7%
10/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Investigations
Blood bilirubin increased
|
10.0%
6/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Gastrointestinal disorders
Nausea
|
58.3%
35/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Gastrointestinal disorders
Vomiting
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33.3%
20/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Gastrointestinal disorders
Diarrhoea
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31.7%
19/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Gastrointestinal disorders
Constipation
|
25.0%
15/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Blood and lymphatic system disorders
Anemia
|
75.0%
45/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Gastrointestinal disorders
Appetite decreased
|
61.7%
37/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Metabolism and nutrition disorders
Hyponatraemia
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26.7%
16/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
6/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
6/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
6/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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General disorders
Adynamia
|
30.0%
18/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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General disorders
Fatigue
|
10.0%
6/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Infections and infestations
Upper respiratory tract infection
|
13.3%
8/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Nervous system disorders
Insomnia
|
15.0%
9/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
|
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Endocrine disorders
Hypothyroidism
|
13.3%
8/60 • From study drug dosed to 30 days after last study drug dose, up to 44 months, SAE was collected from consent, an average of 3.7 year.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place