chronic GVHD with cutaneous involvement among allogeic HCT patients. Chronic graft-versus-host disease
Conditions
Interventions
Intervention group: Baricitinib drug according to the protocol with a dose of 2 mg daily for patients for 3 initial treatment cycles and based on initial findings in three months, up to 6 treatment cy
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patient must be diagnosed with moderate to severe chronic GVHD based on the NIH criteria provided. The therapeutic response to the JAK inhibitor is not limited to a specific organ; thus, involvement of other organs alongside skin involvement is permissible for entry. Patients must be over the age of 18. This is because there is currently insufficient information regarding the drug dosage and side effects of Baricitinib in individuals under 18, and it is preferable that these individuals do not participate in the study. The Karnofsky performance score in patients must be above 50. A patient diagnosed with chronic GVHD must not have responded to treatment with high-dose corticosteroids (1 mg per kg body weight for 1 week, or 0.5 mg of prednisolone per kg body weight every other day for 4 weeks) or must not have had an adequate therapeutic response to at least two prior lines of treatment. If the patient is on another treatment prior to participating in the study, the drug dosage must not have increased in the 4 weeks preceding entry into the study (if it has been stable or is gradually being reduced for tapering, it is acceptable). Patients must have normal organ and bone marrow function as follows: Absolute neutrophil count greater than or equal to 1,000/mcL The patient must have no evidence of active TB in clinical and laboratory tests. In the case of dyslipidemia prior to treatment initiation, the lipid profile must be controlled. Creatinine lower than 1.5 times the upper limit of normal, or creatinine clearance greater than or equal to 50 mL/min/1.73 m². Creatinine clearance should be calculated based on institutional standards. AST(SGOT)/ALT(SGPT) less than or equal to 3 times the upper limit of normal. Total bilirubin less than or equal to 1.5 times the upper limit of normal, unless there is a history of Gilbert's disease. Platelets greater than or equal to 50,000/mcL Hemoglobin greater than or equal to 9 g/dL Absolute lymphocyte count greater than or equal to 500/mcL The primary cancer for which the patient underwent transplantation must have been stable for 3 months before enrollment in the study. The effects of Baricitinib on human embryos are unknown. Approximately 10% of transplant patients maintain their fertility after transplantation. Therefore, women of childbearing age and men must agree to use at least 2 effective methods of contraception (hormonal contraceptive methods; abstinence) for the duration of the study and for at least 7 days prior to exposure to the investigational drug. If a woman becomes pregnant during the study or suspects she is pregnant, or if a male's partner becomes pregnant or suspects she is pregnant during the study, she must immediately inform her physician. The patient must have the ability to understand the conditions of this study and willingness to sign a written consent document.
Exclusion criteria
Exclusion criteria: Immunosuppression or systemic treatment for cGVHD that has begun in the past 4 weeks. Allergy to JAK inhibitors Any serious medical condition in the past 4 weeks that poses an unacceptable risk to the patient if they participate in the study or interferes with their ability to interpret study data, including but not limited to: symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmias, acute kidney injury, or mental illness/social conditions that would preclude compliance with study requirements Uncontrolled infection, including active HIV-1, hepatitis B, or hepatitis C (positive viral load for HBV or HCV with positive HBV surface antibody or HCV antibody). A history of HBV or HCV is permissible in the absence of uncontrolled viral infection. Because the study agent may affect the response to infections, patients with any active viral infection will be excluded from the study. Recurrence or progression of cancer requiring anti-cancer treatment Diagnosis of other cancers besides those for which the transplant was performed, within 2 years prior to enrollment, except for non-melanoma skin cancer or in situ carcinoma of the cervix or breast.? Patients receiving any other investigational agents. NIH respiratory score of 3 Pregnant women are excluded from this study due to the unknown teratogenic effects of baricitinib. Due to the unknown but potentially harmful side effects on breastfed infants resulting from maternal treatment with baricitinib, breastfeeding should be discontinued if the mother is treated with this drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin Ultrasonography. Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: Ultrasound device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin Hydration. Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: skin biometric device.;Tranepidermal Water Loss (TEWL). Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: Tewameter.;Skin PH. Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: skin biometric device.;Skin Elasticity. Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: skin biometric device.;Skin Erythema. Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: skin biometric device.;Skin Marks & Spots, UV Spots, Skin Colour. Timepoint: before intervention and 3, 6 months after intervention. Method of measurement: skin biometric device.;Skin biopsy. Timepoint: before intervention. Method of measurement: 3-5 mm Punch biopsy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactshayan zamani
Tehran University of Medical Sciences
Outcome results
None listed