Trial Outcomes & Findings for Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma (NCT NCT04432506)
NCT ID: NCT04432506
Last Updated: 2025-01-28
Results Overview
Will be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)5.0. CRS will be assessed by both Lee 2014 criteria as well as American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading system.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Within 30 days after infusion of CAR T cells
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
Cohort 1
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after infusion of CAR T cellsWill be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)5.0. CRS will be assessed by both Lee 2014 criteria as well as American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading system.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Incidence of Any Grade Cytokine Release Syndrome (CRS)
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 daysWill be tabulated according to the NCI CTCAE v5.0. CRS will be assessed by both Lee 2014 criteria as well as ASTCT Consensus Grading system. ICANS will be assessed by both CTCAE v5.0 as well as ASTCT Consensus Grading system.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Incidence of Different Grades and Duration of Both CRS and Immune Cell-associated Neurotoxicity Syndrome (ICANS)
CRS
|
10 Participants
|
9 Participants
|
|
Incidence of Different Grades and Duration of Both CRS and Immune Cell-associated Neurotoxicity Syndrome (ICANS)
ICANS
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsWill be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Overall Response Rate
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsWill be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Complete Response Rate
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment to disease progression or death due to any cause whichever happened first, assessed up to 24 monthsWill be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma. Will be estimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Progression Free Survival
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment to death due to any cause, assessed up to 24 monthsWill be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma. Will be estimated using the method of Kaplan and Meier.
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 Participants
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Overall Survival
|
5 Participants
|
8 Participants
|
Adverse Events
Cohort 1
Serious events: 6 serious events
Other events: 10 other events
Deaths: 5 deaths
Cohort 2
Serious events: 4 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1
n=10 participants at risk
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 participants at risk
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Nervous system disorders
Encephalopathy
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/10 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/10 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/10 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Infection
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
General disorders
Cytokine release syndrome
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Infections and infestations
Anorectal infection
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
Other adverse events
| Measure |
Cohort 1
n=10 participants at risk
Anakinra Dose Level 1 (100 mg SQ daily x 7 days starting on Day 0)
|
Cohort 2
n=10 participants at risk
Anakinra Dose Level 2 (100 mg SQ BID x 7 days starting on Day 0)
|
|---|---|---|
|
Investigations
Neutropenia
|
60.0%
6/10 • Number of events 6 • up to 24 months
|
80.0%
8/10 • Number of events 8 • up to 24 months
|
|
Investigations
Thrombocytopenia
|
60.0%
6/10 • Number of events 6 • up to 24 months
|
70.0%
7/10 • Number of events 7 • up to 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
7/10 • Number of events 7 • up to 24 months
|
100.0%
10/10 • Number of events 11 • up to 24 months
|
|
Infections and infestations
Infections
|
40.0%
4/10 • Number of events 4 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
|
Vascular disorders
Hypotension
|
60.0%
6/10 • Number of events 6 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Investigations
Hypofibrinogenemia
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
General disorders
Fever
|
90.0%
9/10 • Number of events 9 • up to 24 months
|
70.0%
7/10 • Number of events 7 • up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 5 • up to 24 months
|
80.0%
8/10 • Number of events 8 • up to 24 months
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 5 • up to 24 months
|
80.0%
8/10 • Number of events 8 • up to 24 months
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 5 • up to 24 months
|
60.0%
6/10 • Number of events 6 • up to 24 months
|
|
General disorders
Pain
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
60.0%
6/10 • Number of events 6 • up to 24 months
|
|
Cardiac disorders
Sinus Tachycardia
|
40.0%
4/10 • Number of events 4 • up to 24 months
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
|
Investigations
ALT increased
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
40.0%
4/10 • Number of events 4 • up to 24 months
|
|
Investigations
AST increased
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Cardiac disorders
Arrhythmia
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
General disorders
Edema limbs
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Insomnia
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Serosal effusion
|
30.0%
3/10 • Number of events 3 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Investigations
Creatinine increased
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Tremors
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
|
Infections and infestations
CMV infection
|
20.0%
2/10 • Number of events 2 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Investigations
Bilirubin increased
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Nervous system disorders
Agitation
|
10.0%
1/10 • Number of events 1 • up to 24 months
|
0.00%
0/10 • up to 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
5/10 • Number of events 5 • up to 24 months
|
40.0%
4/10 • Number of events 4 • up to 24 months
|
Additional Information
Paolo Strati, MD
The University of Texas MD Anderson Cancer Center
Phone: (713) 745-1776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place