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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Graft Versus Host Disease
• Intervention / Treatment: Drug: Human chorionic gonadotropin (hCG); Drug: Prednisone; Drug: Dexamethasone

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).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Cesar H Gutierrez Aguirre, MD; Phone Number: +52 (81) 83891194; Email: hematohu@yahoo.com
• Study Contact Backup: Name: David Gómez Almaguer, MD; Phone Number: +52‭(81) 8348 8510‬; Email: dgomezalmaguer@gmail.com

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Recruiting
      • Universidad Autonoma de Nuevo Leon
      • Contact: Cesar H Gutiérrez Aguirre, MD; Phone Number: + (52) 8183891194; Email: hematohu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group; Oral prednisone 1 mg/kg/day for 14 days or IV dexamethasone 0.15 mg/kg/day for 14 days + human chorionic gonadotropin 2500 IU intramuscular on days 1, 3, and 5 of the protocol. Patients who have at least a partial response by day 7 will receive 3 weekly doses for an additional 4 weeks.	Drug: Human chorionic gonadotropin (hCG); 2500 IU intramuscular on days 1, 3, and 5 of the protocol. Patients who have at least a partial response by day 7 will receive 3 weekly doses for an additional 4 weeks.; Drug: Prednisone; Oral prednisone 1 mg/kg/day for 14 days; Drug: Dexamethasone; IV dexamethasone 0.15 mg/kg/day for 14 days
Active Comparator: Control group; Oral prednisone 1 mg/kg/day for 14 days or IV dexamethasone 0.15 mg/kg/day for 14 days.	Drug: Prednisone; Oral prednisone 1 mg/kg/day for 14 days; Drug: Dexamethasone; IV dexamethasone 0.15 mg/kg/day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of GVHD response	The primary outcome measure for this study is the effectiveness of human chorionic gonadotropin (hCG) when combined with steroids in the treatment of acute graft-versus-host disease (aGVHD) in patients with allogeneic hematopoietic cell transplantation (allo-HCT). This could be assessed using clinical criteria such as improvement in skin, liver, gastrointestinal symptoms, and overall patient condition, evaluated at specified time points (e.g., day 7, day 14, and at the end of the treatment regimen).	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Collaborators: Marisa Romero Martínez; Dr. José Carlos Jaime Perez; Dr. David Gómez Almaguer; Dra. Consuelo Mancias Guerra; Dr. Andrés Gómez de León; Dra. Olga Graciela Catú Rodríguez; Dra. Perla Colunga Pedraza; Dra. Michelle Morcos Sandino

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: human chorionic gonadotropin; Acute GVHD
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Dexamethasone; Prednisone; Chorionic Gonadotropin
• Other Study ID Numbers: HE25-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No