In short
Clinical trials are investigating Hydrocortisone Sodium Succinate in several different settings, including acute lymphoblastic leukemia, pneumonia, and advanced breast cancer. These studies look at safety, dose-finding, and how well treatment works in specific patient groups such as children, young adults, and adults.
Key points
- Clinical trials of Hydrocortisone Sodium Succinate are being done in acute lymphoblastic leukemia, pneumonia, and HER2-positive advanced breast cancer. The studies include Phase 1, Phase 3, and Phase 4 research, so they cover early dose-finding as well as larger treatment studies. The target groups include children, young adults, people with pneumonia, and adults with advanced breast cancer. Main outcomes include disease-free survival, event-free survival, progression-free survival, overall survival, and time to discharge from hospital. One trial also looks at maximum tolerated dose and dose-limiting toxicities. Overall, the trial data show Hydrocortisone Sodium Succinate being studied as part of combination treatment plans in different patient groups.
Clinical trials overview
These records show Hydrocortisone Sodium Succinate being studied in different clinical trials for several conditions, including acute lymphoblastic leukemia, pneumonia, and HER2-positive advanced breast cancer. The trials are all listed as Authorised, and they range from Phase 1 to Phase 4.
The studies are interventional, which means researchers are assigning treatment plans and then measuring results. In the trial data, Hydrocortisone Sodium Succinate is not being studied alone; it appears as part of combination treatment plans.
Acute lymphoblastic leukemia studies
One Phase 3 trial is an international study in Philadelphia chromosome-positive acute lymphoblastic leukemia, a type of blood cancer. It includes 306 participants and compares disease-free survival in standard-risk pediatric patients treated with continuous imatinib plus different chemotherapy backbones. Hydrocortisone Sodium Succinate appears in the intervention list as an intrathecal treatment, which means it is given into the fluid around the spine and brain.
Another large study, ALLTogether, is a Phase 4 protocol for infants, children, and young adults with acute lymphoblastic leukaemia. It has 8,503 participants and aims to improve survival and quality of survival using several randomized and non-randomized interventions. In this protocol, Hydrocortisone Sodium Succinate is also listed as an intrathecal intervention.
A related leukemia protocol for participants 0 to 45 years old is also listed as Phase 4 and authorised. This study uses several treatments and measures event-free survival for the whole protocol, disease-free survival for randomized parts, and the fraction of patients with undetectable MRD after one cycle of blinatumomab in a subgroup with Down syndrome. MRD means minimal residual disease, which is a very small amount of leukemia that can still be found after treatment.
Pneumonia study
The RECOVERY trial is a Phase 3 study in pneumonia with 1,590 participants. It compares study treatments to provide reliable estimates of effects on mortality and time to discharge from hospital. Hydrocortisone Sodium Succinate is listed as an intravenous infusion in this study, meaning it is given through a vein.
The main outcomes are 28-day all-cause mortality and, for patients with influenza only, time to discharge alive from hospital within 28 days. All-cause mortality means death from any cause, not just the lung infection itself.
HER2-positive advanced breast cancer study
The JAZMINE study is a Phase 1 trial in HER2-positive advanced breast cancer with 129 participants. It tests zanidatamab with tucatinib and chemotherapy, using either capecitabine or eribulin mesylate. Hydrocortisone Sodium Succinate appears in the intervention list as an intravenous injection in this study.
This study has two Phase Ib parts that look at the maximum tolerated dose and then set the recommended phase II dose. It also has a Phase II part that measures progression-free survival, which is the time from treatment start until the cancer gets worse or the patient dies. The trial also uses dose-limiting toxicities, meaning serious side effects that help researchers decide which dose is safe enough to continue studying.
Main outcomes and endpoints
The trials measure different endpoints depending on the disease and study phase. In leukemia studies, the main outcomes include disease-free survival and event-free survival, which help show how long patients stay free from relapse or other major events.
In the pneumonia trial, the main outcomes are death within 28 days and hospital discharge within 28 days for influenza patients. In the breast cancer study, the early phase focuses on maximum tolerated dose and recommended phase II dose, while the later phase measures progression-free survival.
Who can participate
The target populations are different across the trials. The leukemia studies focus on infants, children, adolescents, and young adults, including a standard-risk pediatric group and participants up to 45 years old. The pneumonia study includes people with pneumonia, and the breast cancer study includes people with HER2-positive advanced breast cancer.
Because these are clinical trials, each study has its own rules for who can join. The trial records provided here do not list all inclusion and exclusion rules, so the exact eligibility details are not shown in the source data.
Trial phases and study design
Phase 1 studies usually look first at safety and dose, which is why the JAZMINE study measures maximum tolerated dose and dose-limiting toxicities. Phase 3 and Phase 4 studies usually involve larger groups and focus more on how well treatment works in real patients.
The leukemia protocols include randomized comparisons in some parts, meaning participants are assigned by chance to different treatment groups. The ALLTogether protocol also includes non-randomized parts to gather baseline information about disease features, outcomes, and toxicity, and to compare some groups with historical controls. Historical controls are past patient groups used as a comparison.