Using human chorionic gonadotropin to treat acute graft versus host disease
Official title: Evaluation of Human Chorionic Gonadotropin for the Treatment of Acute Graft-versus-host Disease in Patients With Allogeneic Hematopoietic Cell Transplantation
Run by Hospital Universitario Dr. Jose E. Gonzalez · NCT06904599 · Data updated 2026-11-12
This study is testing if adding a hormone called hCG to standard steroid treatment can help people with acute graft versus host disease feel better after their stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Monterrey, Nuevo León) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | January 31, 2026 |
| Study ends | January 31, 2026 |
| Registry record updated | April 3, 2025 |
| Trial ID | NCT06904599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older who have recently developed grades 2 to 4 acute graft versus host disease after allogeneic hematopoietic cell transplantation.
✕Probably not a fit
Patients who have received steroids for more than 3 days in the last week may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy of human chorionic gonadotropin (hCG) in treating acute graft versus host disease (aGVHD) in patients who have recently undergone allogeneic hematopoietic cell transplantation. It will involve 20 patients who will receive either standard steroid treatment or a combination of steroids and hCG. The goal is to determine if the addition of hCG improves treatment outcomes compared to steroids alone. The study aims to provide a more accessible and effective treatment option for patients suffering from aGVHD.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective and accessible option for patients with acute graft versus host disease.
How similar studies have gone: Previous clinical cases have shown that hCG can be therapeutically effective in about 50% of patients with aGVHD, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older. * Any gender. * Post-allogeneic transplantation status (haploidentical or identical) of hematopoietic cells. * Presenting recently onset aGVHD, grades 2 to 4, and requiring systemic steroid use as determined by the treating physician. * Have not received steroids (Prednisone ≥1 mg/kg/day or equivalent dose of another steroid) for more than 3 days in the last week. * Willing to participate in the study by signing informed consent. * If the subject is female and has the potential to procreate (a woman is considered fertile from menarche to postmenopausal stage or after undergoing a permanent contraceptive method), she agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: oral hormonal contraception, intrauterine device, barrier methods (diaphragm, male or female condom, and foam, sponge, or spermicide film), or agrees to remain abstinent. Women who have been postmenopausal for more than a year, undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy are not considered to have reproductive potential. * If the subject is male, he agrees to use one of the following contraceptive methods from the start of the study and for 30 days after the protocol: male condom, or remain abstinent. Exclusion Criteria: * Arterial or venous thrombosis in the past 3 months. * History of thromboembolic disease requiring full-dose anticoagulation. * Diagnosis of active malignant disease. * Uncontrolled infection. * Chronic use of supplemental therapy with sex hormones (estrogen, progesterone, and/or testosterone). * Women with a positive pregnancy test at the time of the initial evaluation. * Women or men of reproductive age who are unwilling to take appropriate precautions to avoid an unwanted pregnancy from the start of the protocol until 30 days after the protocol.
Where it's running
-
Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico Recruiting
Study contacts
- Study coordinator: Cesar H Gutierrez Aguirre, MD
- Email: hematohu@yahoo.com
- Phone: +52 (81) 83891194
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant
This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.
-
Post-transplant dental cleaning to prevent chronic graft-versus-host disease
This will try a dental cleaning about 28 days after an allogeneic stem cell transplant to see if it lowers the chance of chronic graft-versus-host disease in adult transplant recipients.
-
First-line jaktinib plus corticosteroids for acute graft-versus-host disease
This trial will test whether adding jaktinib to standard steroids helps adults with grade II–IV acute graft-versus-host disease after an allogeneic stem cell transplant.
-
Timing of umbilical cord blood infusion and risk of acute graft-versus-host disease after transplant
This trial will test whether giving a single-unit unrelated umbilical cord blood transplant at different times of day changes the chance of acute graft-versus-host disease in people with malignant blood disorders who are in remission.
-
Ruxolitinib treatment for acute graft-versus-host disease
This study is testing if ruxolitinib can help people with acute graft-versus-host disease who haven't improved with regular steroid treatments.
-
Preventing severe acute graft‑versus‑host disease in high‑risk adults with an anti‑CD25 antibody
This trial will try a recombinant humanized anti‑CD25 antibody to prevent severe aGVHD in adults the daGOAT model flags as intermediate‑to‑high risk after allogeneic stem cell transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.