Table of contents
- Clinical trials overview
- Acute lymphoblastic leukemia studies
- Pneumonia study
- HER2-positive advanced breast cancer study
- Main outcomes and endpoints
- Who can participate
- Trial phases and study design
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.[1][2][3][4] The trials are all listed as Authorised, and they range from Phase 1 to Phase 4.[1][2][3][4]
The studies are interventional, which means researchers are assigning treatment plans and then measuring results.[1][2][3][4] In the trial data, Hydrocortisone Sodium Succinate is not being studied alone; it appears as part of combination treatment plans.[1][2][3][4]
Acute lymphoblastic leukemia studies
One Phase 3 trial is an international study in Philadelphia chromosome-positive acute lymphoblastic leukemia, a type of blood cancer.[1] It includes 306 participants and compares disease-free survival in standard-risk pediatric patients treated with continuous imatinib plus different chemotherapy backbones.[1] 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.[1]
Another large study, ALLTogether, is a Phase 4 protocol for infants, children, and young adults with acute lymphoblastic leukaemia.[3] It has 8,503 participants and aims to improve survival and quality of survival using several randomized and non-randomized interventions.[3] In this protocol, Hydrocortisone Sodium Succinate is also listed as an intrathecal intervention.[3]
A related leukemia protocol for participants 0 to 45 years old is also listed as Phase 4 and authorised.[3] 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.[3] MRD means minimal residual disease, which is a very small amount of leukemia that can still be found after treatment.[3]
Pneumonia study
The RECOVERY trial is a Phase 3 study in pneumonia with 1,590 participants.[2] It compares study treatments to provide reliable estimates of effects on mortality and time to discharge from hospital.[2] Hydrocortisone Sodium Succinate is listed as an intravenous infusion in this study, meaning it is given through a vein.[2]
The main outcomes are 28-day all-cause mortality and, for patients with influenza only, time to discharge alive from hospital within 28 days.[2] All-cause mortality means death from any cause, not just the lung infection itself.[2]
HER2-positive advanced breast cancer study
The JAZMINE study is a Phase 1 trial in HER2-positive advanced breast cancer with 129 participants.[4] It tests zanidatamab with tucatinib and chemotherapy, using either capecitabine or eribulin mesylate.[4] Hydrocortisone Sodium Succinate appears in the intervention list as an intravenous injection in this study.[4]
This study has two Phase Ib parts that look at the maximum tolerated dose and then set the recommended phase II dose.[4] 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.[4] The trial also uses dose-limiting toxicities, meaning serious side effects that help researchers decide which dose is safe enough to continue studying.[4]
Main outcomes and endpoints
The trials measure different endpoints depending on the disease and study phase.[1][2][3][4] 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.[1][3]
In the pneumonia trial, the main outcomes are death within 28 days and hospital discharge within 28 days for influenza patients.[2] 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.[4]
Who can participate
The target populations are different across the trials.[1][2][3][4] The leukemia studies focus on infants, children, adolescents, and young adults, including a standard-risk pediatric group and participants up to 45 years old.[1][3] The pneumonia study includes people with pneumonia, and the breast cancer study includes people with HER2-positive advanced breast cancer.[2][4]
Because these are clinical trials, each study has its own rules for who can join.[1][2][3][4] 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.[1][2][3][4]
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.[4] Phase 3 and Phase 4 studies usually involve larger groups and focus more on how well treatment works in real patients.[1][2][3]
The leukemia protocols include randomized comparisons in some parts, meaning participants are assigned by chance to different treatment groups.[1][3] 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.[3] Historical controls are past patient groups used as a comparison.[3]
