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RECRUITINGPHASE2

Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

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

NCT06904599•Hospital Universitario Dr. Jose E. Gonzalez

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Summary

Graft-versus-host disease is a complication of allogeneic hematopoietic cell transplantation with high morbidity and mortality. The standard treatment is corticosteroids, and based on the response within 3 to 7 days, a second-line therapy is added, which is expensive and not easily accessible. The administration of human chorionic gonadotropin has shown therapeutic effectiveness in 50% of patients in reported clinical cases.

Detailed Description

The study will include 20 patients with recent-onset allogeneic hematopoietic cell transplantation and GVHD who attend the Hematology Service at the University Hospital and meet the inclusion criteria, to receive conventional treatment with steroids (prednisone 1 mg/kg/day for 14 days) or combined treatment (hCG 2500 IU, IM + prednisone 1 mg/kg/day for 14 days).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, Mexico

Key Dates

Start Date

February 1, 2025

Primary Completion Date

January 31, 2026

Completion Date

January 31, 2026

Last Updated

April 3, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Graft Versus Host Disease

Interventions

Human chorionic gonadotropin (hCG)

DRUG

Prednisone

DRUG

Dexamethasone

DRUG

Contacts

Cesar H Gutierrez Aguirre, MD

CONTACT

+52 (81) 83891194 hematohu@yahoo.com

David Gómez Almaguer, MD

CONTACT

+52‭(81) 8348 8510‬dgomezalmaguer@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

Inclusion Criteria

Exclusion Criteria

Managed Access Programs for INC424, Ruxolitinib

Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases

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