Using human chorionic gonadotropin to treat acute graft versus host disease

Evaluation of Human Chorionic Gonadotropin for the Treatment of Acute Graft-versus-host Disease in Patients With Allogeneic Hematopoietic Cell Transplantation

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
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez (Academic / other)
• Drugs / interventions: Prednisone
• Locations: 1 site (Monterrey, Nuevo León)
• Trial ID: NCT06904599 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who have received steroids for more than 3 days in the last week may not benefit from this study.

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 performed: Previous clinical cases have shown that hCG can be therapeutically effective in about 50% of patients with aGVHD, suggesting potential success for this approach.

Eligibility 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 this trial is running

Monterrey, Nuevo León

• Universidad Autónoma de Nuevo León — Monterrey, Nuevo León, Mexico (Recruiting)

Study contacts

• Study coordinator: Cesar H Gutierrez Aguirre, MD

Conditions Acute Graft Versus Host Disease; Acute GVHD; human chorionic gonadotropin