Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00447460
Eligibility Criteria:
Inclusion Criteria:
* Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
* Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
* Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
* Patients with ages between 18 and 65 years.
* Signature of informed consent form is required to be done by patient and donor.
Exclusion Criteria:
* Patients whose hematopathology has not been controlled by the transplant or is in progress.
* Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
* Patients with an inadequate cardiac or pulmonary function.
* Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
* Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
* Pregnant females or childbearing potential who are not on adequate contraceptive measures.
* Patients \<18 or \>65 years.
* Patients who do not sign the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00447460
Study Brief:
Protocol Section:
NCT00447460