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| Name | Class |
|---|---|
| Marisa Romero Martínez | UNKNOWN |
| Dr. José Carlos Jaime Perez | UNKNOWN |
| Dr. David Gómez Almaguer | UNKNOWN |
| Dra. Consuelo Mancias Guerra |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | 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. |
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| Control group | Active Comparator | Oral prednisone 1 mg/kg/day for 14 days or IV dexamethasone 0.15 mg/kg/day for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cesar H Gutierrez Aguirre, MD | Contact | +52 (81) 83891194 | hematohu@yahoo.com | |
| David Gómez Almaguer, MD | Contact | +52(81) 8348 8510 | dgomezalmaguer@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autónoma de Nuevo León | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D011241 | Prednisone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| UNKNOWN |
| Dr. Andrés Gómez de León | UNKNOWN |
| Dra. Olga Graciela Catú Rodríguez | UNKNOWN |
| Dra. Perla Colunga Pedraza | UNKNOWN |
| Dra. Michelle Morcos Sandino | UNKNOWN |
Clinical, longitudinal, prospective, phase 2, randomized, comparative, open-label study.
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| Prednisone | Drug | Oral prednisone 1 mg/kg/day for 14 days |
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| Dexamethasone | Drug | IV dexamethasone 0.15 mg/kg/day for 14 days |
|
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |