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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07381205
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria
1. Adult male or female, age ≥18
2. Undergoing allogeneic SCT at UAB for any indication and any donor source.
3. For patients in cohort 1: Patients deemed high-risk for developing high-risk TA-TMA as stated by any of the following criteria\*:
1. BMI \> 35\[42\]
2. Mismatched donor (either Haploidentical or Mismatched Unrelated donor)\[18, 29\]
3. Non-Malignant Transplant Indication (Severe Aplastic Anemia or Sickle Cell Disease)\[18, 43\]
4. Acute Lymphoblastic Leukemia (any kind)\[18, 31\]
5. African American, Hispanic, Asian or Native American Ethnicity \[44\]
6. Myeloablative Conditioning Regimen\[18\]
7. Pre-Existing Renal Disease\*\* (defined as any of the following: 24 Hr Creatinine Clearance \<60, baseline serum creatinine \> 1.2, 24 hr proteinuria \>150mg or random spot urine Protein Creatinine ratio \> 150mg/g)\[20, 45\]
8. TBI-containing conditioning regimen \>400cGy \[46\]
9. Prior Autologous or Allogeneic SCT\[45\]
* \*Some of these criteria have been adapted from pediatric literature due to a higher number of publications in that setting and in cases where the adult data is lacking or contradictory.
* \*\*Proteinuria thresholds are obtained from KDIGO guidelines and include moderate and severe levels of proteinuria\[47\].
4. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.
5. For patients in cohort 2: Patients who develop GVHD with any of the following characteristics and were not included in cohort 1
1. Grade III-IV aGVHD, or SR-aGVHD of any grade, whichever occurs first
2. Moderate to Severe cGVHD or SR-cGVHD of any grade, whichever occurs first
6. For patients in cohort 3: Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive eculizumab
Exclusion Criteria:
* Exclusion Criteria
1. Any other active malignancy requiring treatment or with expected survival ≤1 year.
2. Patients with psychiatric illness or social situations that would limit compliance with the study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07381205
Study Brief:
Protocol Section:
NCT07381205