B Cell ALL, B-Cell Lymphoma, B-cell Non Hodgkin Lymphoma
Conditions
Brief summary
This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.
Interventions
DRUGAnakinra
100mg subcutaneous
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (age \>/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study
Exclusion criteria
* Patients with uncontrolled systemic fungal and bacterial infections * Patients with known hypersensitivity to E. coli-derived proteins * Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) * Women who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities | 4 weeks | Determine the rate of severe neurotoxicities, \>/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells |
| Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation | 28 days from the start of treatment | proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment. |
Countries
United States
Outcome results
None listed