Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test hCG (human chorionic gonadotropin).

It had 1 arm (groups): Ruxolitinib;hCG (Pregnyl®) ;Corticosteroids (experimental).

The registry classes the interventions as drug.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 12 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Renal: Serum creatinine ≤2.5x upper limit of normal (ULN). Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17-year-olds).

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: progressive malignancy; uncontrolled bacterial, fungal, parasitic, or viral infection at initiation of protocol treatment; unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-06-05 with completion listed for 2026-02-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Best response of treatment in adult and children (time frame: 28 days after therapy).

It also tracked 9 secondary outcomes, for example Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls, Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls, To assess patient quality of life on study, Determine 1-year overall survival and Collect blood samples and rectosigmoid biopsies for future correlative studies.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of hCG (human chorionic gonadotropin) in 10 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.