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Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment

ConditionAcute Graft Versus Host Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Dr. Jose E. Gonzalez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Arterial or venous thrombosis in the past 3 months.

History of thromboembolic disease requiring full-dose anticoagulation.

Diagnosis of active malignant disease.

Uncontrolled infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Human chorionic gonadotropin (hCG)

    Drug

    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.

  • Prednisone

    Drug

    Oral prednisone 1 mg/kg/day for 14 days

  • Dexamethasone

    Drug

    IV dexamethasone 0.15 mg/kg/day for 14 days

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Study groupActive comparator 3 interventions
Group B: Control groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario Dr. Jose E. Gonzalez

Lead sponsor

Marisa Romero Martínez

Collaborator

Dr. José Carlos Jaime Perez

Collaborator

Dr. David Gómez Almaguer

Collaborator

Dra. Consuelo Mancias Guerra

Collaborator

Dr. Andrés Gómez de León

Collaborator

Dra. Olga Graciela Catú Rodríguez

Collaborator

Dra. Perla Colunga Pedraza

Collaborator

Dra. Michelle Morcos Sandino

Collaborator

Source ClinicalTrials.gov
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