Solu-Cortef (hydrocortisone sodium succinate injection) / Pfizer - LARVOL DELTA

HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study (clinicaltrials.gov) - P=N/A | N=180 | Recruiting | Sponsor: Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo | Trial completion date: Jul 2024 ➔ Feb 2027 | Trial primary completion date: Apr 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Critical care • Infectious Disease • Pneumonia • Respiratory Diseases

AALL1131: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations (clinicaltrials.gov) - P3 | N=5949 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Central Nervous System Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • ETV6 • KMT2A • RUNX1

Infusion-Related Reactions (IRR) and Management in Patients With Red Blood Cell (RBC) Transfusion-Dependent (TD) Relapsed or Refractory Lower-Risk Myelodysplastic Syndromes (LR-MDS) Treated With Imetelstat From the IMerge Phase 3 Trial (JADPRO 2025) - P2/3 | "Background/Significance • Myelodysplastic syndromes (MDS) are hematologic malignancies marked by ineffective hematopoiesis, cytopenias, and an elevated risk of progression to acute myeloid leukemia1 •Imetelstat is a first-in-class, direct, and competitive inhibitor of telomerase enzymatic activity, approved in the United States (US) for the treatment of adult patients with low- to intermediate-1-risk MDS with transfusion- dependent (TD) anemia requiring ≥4 red blood cell (RBC) units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA)2 -Imetelstat is administered as an intravenous (IV) infusion over 2 hours every 4 weeks • Approval was based on the pivotal Phase 3 IMerge trial (NCT02598661), a multinational, randomized, double-blind, Phase 2/3 trial of imetelstat versus placebo in patients with RBC-TD, ESA-relapsed, refractory, or ineligible, and non-del(5q) lower-risk MDS Results showed..."

Clinical • P3 data • Acute Myelogenous Leukemia • Anemia • Dermatology • Hematological Malignancies • Immunology • Leukemia • Musculoskeletal Pain • Myelodysplastic Syndrome • Neutropenia • Pruritus • Thrombocytopenia • Urticaria

Radiation recall reactions triggered by COVID-19 infection in a patient with buccal cancer; A clinical report and review of the literature. (PubMed, IDCases) - "An RRR was diagnosed, and she was admitted for treatment with intravenous sulbactam/ampicillin and intravenous hydrocortisone sodium succinate. Her subsequent course has been uneventful, with no flareup of the RRR. This case is presented along with a review of relevant literature."

Journal • Dermatology • Infectious Disease • Novel Coronavirus Disease • Oncology • Otorhinolaryngology • Respiratory Diseases • CRP

AALL1231: Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma (clinicaltrials.gov) - P3 | N=847 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD2 • CD20 • CD22 • CD34 • CD5 • CD7 • CD8 • MPO

Venetoclax Basket Trial for High Risk Hematologic Malignancies (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: Andrew E. Place, MD | Recruiting ➔ Active, not recruiting | N=92 ➔ 13

Enrollment change • Enrollment closed • Pan tumor • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • ABL1 • BCL2 • BCR • FLT3 • IKZF1 • KMT2A

Hormonal Mechanisms of Sleep Restriction - Axis Study (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Peter y. Liu | Trial completion date: Mar 2025 ➔ Jun 2026

Trial completion date

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Trial completion date: Jul 2024 ➔ Jun 2026

Trial completion date

Prolonged Subacute Thyroiditis Refractory to Chronic Steroid Treatment and Requiring Thyroidectomy (ATA 2025) - "He underwent a total thyroidectomy after 9 months of prednisone treatment and surgical pathology revealed nodular hyperplasia.Postoperatively he failed sequential cosyntropin stimulation tests (cortisol 12.5 µg/d) and required a hydrocortisone taper for 1.5 years. He achieved euthyroidism on levothyroxine 137 mcgs daily replacement.Discussion This case illustrates a rare occurrence of prolonged subacute thyroiditis requiring long-term corticosteroid therapy that led to exogenous Cushing's syndrome. In patients with significant comorbidities, prolonged corticosteroid exposure necessitates vigilant monitoring for steroid related risks. Surgical intervention should be considered for such patients whose thyroiditis relapses after a recommended initial trial of steroid treatment."

Late-breaking abstract • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • CNS Disorders • Congestive Heart Failure • Coronary Artery Disease • Cushing’s Disease • Diabetes • Dyslipidemia • Endocrine Disorders • Genetic Disorders • Heart Failure • Hypertension • Inflammation • Metabolic Disorders • Mood Disorders • Movement Disorders • Musculoskeletal Pain • Nephrology • Obesity • Psychiatry • Pulmonary Disease • Renal Disease • Sleep Disorder • Type 2 Diabetes Mellitus

AALL1821: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov) - P2 | N=461 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting | N=300 ➔ 461

Enrollment change • Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Developmental Disorders • Genetic Disorders • Hematological Malignancies • Leukemia • Oncology • CD19

Dual-modified Liposomes Encapsulating Nucleic Acids (pApoE2 or pGFP) for Transport Studies Across a Hydrocortisone-enhanced In Vitro Blood-brain Barrier Model for CNS Therapeutic Screening. (PubMed, Pharm Res) - "Hydrocortisone enhanced the BBB properties of the in vitro model, making it more representative of the in vivo BBB. Dual-modified liposomes demonstrated superior efficacy in delivering genetic materials across the BBB, providing a promising approach for therapeutic interventions in neurodegenerative diseases like Alzheimer's."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders

Evaluation of Stress Dose Hydrocortisone Tapers in Septic Shock. (PubMed, Hosp Pharm) - "The primary outcome was the percentage of patients who received a hydrocortisone taper. In patients admitted to an ICU for septic shock started on stress dose hydrocortisone there was heterogeneity in the duration of stress dose hydrocortisone and the implementation, method, and length of a taper. This highlights a need for additional attention to methods of discontinuation of stress dose steroids and implications on patient centered outcomes."

Journal • Critical care • Septic Shock

Twin Discordance In Primary Adrenal Insufficiency: Hyperpigmentation As The First Overlooked Symptom (ENDO 2025) - "She was treated with IV hydrocortisone (Solu-Cortef) 10 mg twice daily, resulting in rapid symptom improvement and correction of hyponatremia. She was discharged on oral hydrocortisone and fludrocortisone with a referral for endocrinology follow-up... In summary, mucocutaneous hyperpigmentation may represent the first sign of primary adrenal insufficiency. The stark contrast with the patient's identical twin highlighted this symptom's significance, yet it still did not prompt additional investigation in the absence of other symptoms. Although the twin sibling is currently asymptomatic, genetic testing and regular evaluations should be conducted to ensure early diagnosis and timely intervention."

Discordant • Late-breaking abstract • Cardiovascular • Cognitive Disorders • Endocrine Disorders • Fatigue • Heart Failure • Immunology • Nephrology • Rare Diseases • Renal Disease

Retrospective Analysis of 27 Adrenal Insufficiency Patients Managed with Cortisol Pump (ENDO 2025) - "One developed severe COVID and was on high doses of injectable steroids in ICU for 3 weeks and eventually transitioned to oral Dexamethasone. 27 Patients, 25 are female. Average age at the start of the pump is 42 yo (11-61yo).9 (33%) patients have primary AI, 2 with non-classical CAH, 7 have pituitary, 9 (33%) tertiary AI due to overuse of steroids for other conditions. 1 is on Solu-Medrol per pump (Solu-Cortef did ont work) and the rest on Solu-Cortef."

Retrospective data • Celiac Disease • Cystic Fibrosis • Endocrine Disorders • Gastrointestinal Disorder • Genetic Disorders • Immunology • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

Case of Adrenal Insufficiency in 11 yo Male on Cortisol Pump. (ENDO 2025) - "He required frequent rescue Solu-Cortef injections, emergency room trips and admissions to the hospital. This case demonstrates the potential of cortisol pumps to improve the quality of life of patients with inadequately controlled adrenal insufficiency long-term. Delayed Release prednisone (Rayos) can help with management of poorly controlled AI."

Clinical • Autism Spectrum Disorder • Autoimmune Hepatitis • Cardiovascular • Endocrine Disorders • Fatigue • Genetic Disorders • Hepatology • Hypoglycemia • Immunology • Inflammation • Metabolic Disorders • Nephrology • Portal Hypertension • Renal Disease

Hydrocortisone Dosing Frequency in Intensive Care Unit Patients With Septic Shock: A Comparison of 2 Regimens. (PubMed, Ann Pharmacother) - "There was no difference in the primary outcome of time to shock reversal or any secondary outcome between hydrocortisone groups. This alternative hydrocortisone dosing strategy may warrant further evaluation in large, prospective studies."

Clinical • Journal • Critical care • Diabetes • Infectious Disease • Septic Shock

ALL Adult Consortium Trial: Adult ALL Trial (clinicaltrials.gov) - P2 | N=112 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed

Trial completion • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Overcoming the challenge: weaning corticosteroids in glucocorticoid-induced adrenal insufficiency. (ESPE-ESE 2025) - "A hydrocortisone day curve confirmed that she was a slow metabolizer of hydrocortisone SST was repeated in on 5mg; T=0min cortisol 111nmol/L, ACTH 45.6ng/L T=30min cortisol 120nmol/L T=60 min cortisol 125nmol/L She continues to wean from 5mg day to 2.5mg according to the protocol below and we aim to wean her off steroids completely...These results suggest that conventional hydrocortisone replacement in doses as low as 7.5mg/5mg/2.5mg can cause persistent HPA axis suppression. There is a need for prospective studies to evaluate weaning protocols."

Diabetes • Endocrine Disorders • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Metabolic Disorders • Nephrology • Osteoporosis • Renal Disease • Rheumatology

Patient and caregiver experiences with hydrocortisone injections in adrenal crisis: a mixed-methods cross-sectional study. (PubMed, Front Endocrinol (Lausanne)) - "Notably, 97% of participants expressed a preference for a hydrocortisone autoinjector to enhance self-injection capabilities. Effective adrenal crisis management requires comprehensive, evidence-based interventions across patient, healthcare, and societal levels. This should include the development of user-friendly hydrocortisone delivery devices, individualized patient education, healthcare system reforms, and public awareness."

Journal • Observational data • Congenital Adrenal Hyperplasia • Endocrine Disorders • Mood Disorders • Nephrology • Psychiatry • Renal Disease

Immunomodulatory Effects of Polysaccharides from Porphyra haitanensis in Hydrocortisone-Induced Immunocompromised Mice. (PubMed, Foods) - "This study investigated the immunomodulatory effect of polysaccharides from Porphyra haitanensis (PHP) using a hydrocortisone-induced immunosuppressive model. Western blot results revealed that PHP activates the TLR4/NF-κB pathway. These findings suggested that PHP exerts immunomodulatory effects on both the innate and adaptive immune systems."

Journal • Preclinical • Immunology • CD4 • CD8 • GATA3

ALL Adult Consortium Trial: Adult ALL Trial (clinicaltrials.gov) - P2 | N=112 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Dec 2024 ➔ Mar 2025

Trial completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

EVALUATION OF STEROID CHOICE ON VASOPRESSOR REQUIREMENTS DURING A HYDROCORTISONE SHORTAGE (SCCM 2025) - "The pre-intervention group included treatment with hydrocortisone 50 mg intravenous every six hours from March 2022 to August 2022, and the post-intervention group included treatment with dexamethasone 8 mg intravenous daily from March 2023 to August 2023. No statistically significant differences were observed in shock resolution, mortality rates, or length of stay, indicating that dexamethasone may be an appropriate alternative to hydrocortisone in septic shock."

Septic Shock

EMERGENCE OF ADRENAL INSUFFICIENCY AFTER TREATMENT OF MILIARY TUBERCULOSIS (SCCM 2025) - "The patient's vitals and sodium corrected while on a hydrocortisone taper, but on hospital day eight, she developed altered mental status and SIRS criteria concerning for sepsis...Given concern for adrenal insufficiency secondary to miliary TB and its treatment with rifampin, fludrocortisone was added to dexamethasone to meet both mineralocorticoid and glucocorticoid needs...Interestingly as well is that through rifampin's pharmacokinetics, it can also induce an adrenal insufficiency in this patient population. This case highlights the importance of appropriate hormonal replacement therapy when treating adrenal insufficiency in patients with miliary TB and emphasizes the need for awareness of this complication."

Cardiovascular • Endocrine Disorders • Heart Failure • Hypotension • Infectious Disease • Nephrology • Renal Disease • Respiratory Diseases • Septic Shock • Tuberculosis

AALL15P1: Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement (clinicaltrials.gov) - P2 | N=78 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Dec 2024

Trial completion • Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A

Venetoclax Basket Trial for High Risk Hematologic Malignancies (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Andrew E. Place, MD | Trial completion date: Apr 2027 ➔ Jul 2028 | Trial primary completion date: Apr 2025 ➔ Jul 2026

Pan tumor • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • ABL1 • BCL2 • BCR • FLT3 • IKZF1 • KMT2A