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Therapeutic Hydrocortisone

Phase 2

Non-hodgkin Lymphoma | Small molecule | Oncology |Gilead Sciences, Inc.|Trials Updated: Oct 2, 2026

Therapeutic Hydrocortisone development status

Highest phase Phase 2
Registered trials 2 across 2 sponsors since Oct 2007

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Therapeutic Hydrocortisone clinical trials

Therapeutic Hydrocortisone · 1 trial · 5 indications

Phase 2 1
NCT07763210Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin LymphomaNon-hodgkin Lymphoma
RECRUITING59 Analytics
PHASE2RECRUITING
Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma
Non-hodgkin Lymphoma
NCT0776321059
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Study Endpoints

Primary Endpoints

Efficacy of IT therapy to reduce high-grade ICANS in participants who receive axi-cel in NHL compared to historical experience
From first IT therapy through 14 days from last IT therapy (Up to 3 months)

Incidence of \> Grade 3 ICANS after IT therapy in subjects with grade 1-2 ICANS

Progression free survival
From the day of CAR T therapy infusion to objective disease progression, initiation of any non-protocol anti-lymphoma therapy, or death from any cause, up to 3 months.

Will be analyzed using the Kaplan-Meier method to estimate the survival distribution.

Secondary Endpoints

Impact of IT therapy on CAR T toxicities
From first IT therapy through 14 days from last IT therapy (Up to 3 months)
Adverse events from IT therapy
From first IT therapy tthrough 14 days from last IT therapy (Up to 3 months)
Feasibility of IT therapy
time from onset of ICANS to administration of first IT therapy
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hydrocortisone + Cytarabine + Dexamethasone or MethylprednisoloneEXPERIMENTALDrugs will be given at onset of grade 1/2 ICANS after Axi-cel or Brexu-cel
Prophylactic corticosteroids with DexamethasoneACTIVE_COMPARATORDrugs will be given at onset of grade 1/2 ICANS after Axi-cel or Brexu-cel

Interventions

NameTypeDescription
Therapeutic HydrocortisoneDRUG100 mg IT with onset of grade 1/2 ICANS
CytarabineDRUG100 mg IT with onset of grade 1/2 ICANS
DexamethasoneDRUGIV 10mg
MethylprednisoloneDRUG1g daily until adverse events resolves
CyclophosphamideDRUGGiven as standard of care
Axicabtagene CiloleucelBIOLOGICALGiven as standard of care
Brexucabtagene AutoleucelBIOLOGICALGiven as standard of care
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically confirmed non-Hodgkin Lymphoma, including the following types defined by the World Health Organization (2017) or International Consensus Classification (2022): * Diffuse large B-cell lymphoma (DLBCL) * Primary mediastinal large B-cell l...

Countries:United States
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