Transplant Associated Microangiopathy TAMNCT07381205
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
An observational study of Transplant Associated Microangiopathy TAM and Transplant Complication, run by Manuel Ricardo Espinoza-Gutarra at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Associated Microangiopathy TAM, Transplant Complication
- Type of treatment
- Injection or infusion
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult male or female, age ≥18
- Undergoing allogeneic SCT at UAB for any indication and any donor source.
- For patients in cohort 1: Patients deemed high-risk for developing high-risk TA-TMA as stated by any of the following criteria*:
- BMI > 35[42]
- Mismatched donor (either Haploidentical or Mismatched Unrelated donor)[18, 29]
- Non-Malignant Transplant Indication (Severe Aplastic Anemia or Sickle Cell Disease)[18, 43]
Show all 19Show fewer
- Acute Lymphoblastic Leukemia (any kind)[18, 31]
- African American, Hispanic, Asian or Native American Ethnicity [44]
- Myeloablative Conditioning Regimen[18]
- 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]
- TBI-containing conditioning regimen >400cGy [46]
- 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].
- Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.
- For patients in cohort 2: Patients who develop GVHD with any of the following characteristics and were not included in cohort 1
- Grade III-IV aGVHD, or SR-aGVHD of any grade, whichever occurs first
- Moderate to Severe cGVHD or SR-cGVHD of any grade, whichever occurs first
- For patients in cohort 3: Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive narsoplimab, eculizumab or other complement inhibitor.
Who cannot join
- Any other active malignancy requiring treatment or with expected survival ≤1 year.
- Patients with psychiatric illness or social situations that would limit compliance with the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35294
About this study
Official title: Prospective Evaluation of Transplant Associated Thrombotic Microangiopathy (TA-TMA) Markers in a High-risk Cohort of Adults Undergoing Allogeneic Stem Cell Transplantation (SCT)
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.
Read the detailed description
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.
- Keywords
- Transplant Associated Thrombotic Microangiopathy, Allogeneic Stem Cell Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Main Cohort of patients who fulfill Inclusion Criteria | |
| 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 | |
| Cohort 3 | Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive narsoplimab, eculizumab or other complement inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: From enrollment until 1 year post SCT
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From enrollment until 1 year post SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start15 Jan 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant Associated Microangiopathy TAMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manuel Ricardo Espinoza-Gutarra
- Sponsor type
- University, hospital or other
- Collaborators
- BMS Foundation, Viracor Eurofins, Robert A. Winn Diversity in Clinical Trials Award Program
- Responsible party
- Sponsor-investigator, Manuel Ricardo Espinoza-Gutarra, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381205
- Sponsor's protocol ID
- IRB-30005854 (2537)
- Other IDs
- Robert A. Winn CDA
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Transplant Associated Thrombotic Microangiopathy (TA-TMA) Markers in a High-risk Cohort of Adults Undergoing Allogeneic Stem Cell Transplantation (SCT)
- ClinicalTrials.gov ID
- NCT07381205
- Acronym / sponsor ID
- IRB-30005854 (2537)
- Keywords
- Transplant Associated Thrombotic Microangiopathy, Allogeneic Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Manuel Ricardo Espinoza-GutarraUniversity, hospital or other
- Collaborators
- BMS Foundation, Viracor Eurofins, Robert A. Winn Diversity in Clinical Trials Award Program
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Main Cohort of patients who fulfill Inclusion Criteria |
| 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 |
| Cohort 3 | – | –Patients included in either cohort 1 or 2 who are diagnosed with TA-TMA and receive narsoplimab, eculizumab or other complement inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (19 listed)
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Objectives
Time frame: From enrollment until 1 year post SCT
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).
Co-Primary Objective
Time frame: From enrollment until 1 year post SCT
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
4 secondary outcomes
Secondary Objectives
Time frame: From enrollment until 1 year post SCT
Secondary Objective
Time frame: From enrollment until 1 year post SCT
Secondary Objective
Time frame: From enrollment until 1 year post SCT
Secondary Objective
Time frame: From enrollment until 1 year post SCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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GVHD - Graft-Versus-Host Disease, Infections After HSCT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant Associated Microangiopathy TAM and Transplant Complication, run by Manuel Ricardo Espinoza-Gutarra at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel R Espinoza Gutarra, M.D. (205-975-2576, mgutarra@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objectives (time frame: From enrollment until 1 year post SCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.