An observational study in Transplant Associated Microangiopathy TAM and Transplant Complication, sponsored by Manuel Ricardo Espinoza-Gutarra. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Manuel Ricardo Espinoza-Gutarra · Observational
The goal of this observational study is to learn about the incidence of Transplant Associated Thrombotich Microangiopathy (TA-TMA), which is a known but underreported complication of Allogeneic Stem Cell Transplant (SCT). The main question it aims to answer is:
What is the incidence of TA-TMA in adults undergoing SCT? How does TA-TMA diagnosis impact survival and other outcomes? Patients undergoing SCT will be eligible for this study, which will consist of collection of biological samples and standard clinical follow up.
This will be a prospective non-interventional study that will include patients undergoing allogeneic stem cell transplant (SCT) deemed to be at high risk for developing Transplant Associated Thrombotic Microangiopathy (TA-TMA). All patients will have prospective biospecimens collected per study schedule starting prior to SCT. Biospecimens will be collected for use in translational testing and sent to Viracor for commercial testing. Results of commercial testing will be made available to treating physicians. Diagnosis of TA-TMA will be made based on clinical and laboratory values according to existing consensus guidelines, however, therapeutic decisions will be left up to the treating clinical team. Patients will be followed up for clinical outcomes.
This is the only study on the registry with Manuel Ricardo Espinoza-Gutarra as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing allogeneic stem cell transplant (SCT) deemed to be at high risk for developing Transplant Associated Thrombotic Microangiopathy (TA-TMA) as per inclusion criteria.
Inclusion Criteria:
Inclusion Criteria
For patients in cohort 1: Patients deemed high-risk for developing high-risk TA-TMA as stated by any of the following criteria*:
Prior Autologous or Allogeneic SCT[45]
For patients in cohort 2: Patients who develop GVHD with any of the following characteristics and were not included in cohort 1
Exclusion Criteria:
Exclusion Criteria
Main Cohort of patients who fulfill Inclusion Criteria
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
Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive eculizumab
Primary Objectives
The primary objective of the study is to report the rates of high-risk TA-TMA in a cohort for high-risk patients undergoing allogeneic SCT. High-risk TA-TMA will be defined as per the ASTCT Harmonization Criteria which will include the TMA Harmonization panel consensus recommended diagnostic criteria and any of the high-risk TA-TMA features (Schoettler et al. TCT March 2023).
Time frame: From enrollment until 1 year post SCT
Co-Primary Objective
To evaluate rates of Non-Relapse Mortality (NRM) in patients with and without TA-TMA. NRM is defined as the rate of death from any cause in patients who do not exhibit any sign of relapse or progression of their underlying hematologic malignancy
Time frame: From enrollment until 1 year post SCT
Secondary Objectives
* To evaluate rates of Overall Survival (OS) in patients with and without high-risk TA-TMA * OS is defined as the time from the date of SCT until death.
Time frame: From enrollment until 1 year post SCT
Secondary Objective
-To evaluate rates of Graft Versus Host Free Relapse Free Survival (GFRS) in patients with and without high-risk TA-TMA. GRFS is defined as the time from the date of SCT until occurrence of grade III-IV aGVHD, and or cGVHD requiring systemic immune suppression, and or disease progression or death whichever comes first.
Time frame: From enrollment until 1 year post SCT
Secondary Objective
-To validate previously described risk factors and prognostic scores for the development of high-risk TA-TMA -We will compare other prognostic markers that have been described in the literature such as EASIX score, degree of proteinuria among others to evaluate their correlation with rate and severity of TA-TMA
Time frame: From enrollment until 1 year post SCT
Secondary Objective
-To evaluate kinetics of sC5b-9 in patients with and without high-risk TA-TMA -These analytes will be obtained as per study procedure and their changes will be described.
Time frame: From enrollment until 1 year post SCT
Exploratory Objectives
-To evaluate the impact of therapeutic interventions by treating physicians on biomarkers and clinical outcomes These analytes will be obtained as per study procedure and their changes will be described both in isolation and in association with prespecified variables
Time frame: From enrollment until 1 year post SCT
Exploratory Objective
-To evaluate the association between high-risk TA-TMA development and relapse. Relapse is defined as the rate of patients having their underlying hematologic malignancy relapse or progress after SCT
Time frame: From enrollment until 1 year post SCT
Exploratory Objective
To evaluate, using cohort 3, the association between CH50 levels, eculizumab through levels and high-risk TA-TMA response to eculizumab treatment. These analytes will be obtained as per study procedure and their changes will be described both in isolation and in association with other, pre-specified, variables
Time frame: From enrollment until 1 year post SCT
Exploratory Objective
-To evaluate Patient Reported Outcomes (PROs) in patients with and without high-risk TA-TMA PROs will be obtained at pre-determined times for all patients in the study, the results will be reported descriptively.
Time frame: From enrollment until 1 year post SCT
Plan to share: No
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