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:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT00409695
Eligibility Criteria:
Inclusion Criteria:
1. Patients who underwent their first allogeneic transplant for any malignancy and with any cell (bone marrow, peripheral stem cell, cord blood) or donor (matched or mismatched related or unrelated) source.
2. Biopsy-proven, grade II-IV aGVHD following allogeneic hematopoietic stem cell transplantation (HSCT) of any source (bone marrow, peripheral blood or cord blood stem cells). Enrollment may be started prior to results of biopsy in cases of high clinical suspicion for aGVHD.
3. Early steroid-refractory aGVHD. This is defined as any NR or PD after a minimum of 3 days and not more than 1 week of 1 mg/kg/day of methylprednisolone.
4. Ability to sign informed consent.
5. Ability to return for clinical follow-up as specified in the protocol.
6. Inability to taper as defined by patients on \< or = 1 mg/kg/day of methylprednisolone but unable to further taper without resultant increase of acute GVHD stage.
7. Patients with a reflare of a GVHD defined as worsening of 1 stage of acute GVHD in a patient who initially responded.
Exclusion Criteria:
1. Relapsed malignancy.
2. Acute GVHD as a result of a second or subsequent transplant or donor lymphocyte infusion (DLI).
3. Active, uncontrolled infection.
4. Patients who have received any second-line of immunosuppressive treatment for GVHD beyond corticosteroids and calcineurin inhibitors. Topical steroids, oral budesonide and extracorporeal photochemotherapy started at the time of steroids are allowed.
5. Life-threatening infusion reaction or hypersensitivity to any formulation of ATG in the past.
6. Patients who are pregnant or are breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00409695
Study Brief:
Protocol Section:
NCT00409695