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Observational Study on Transplant Associated Thrombotic Microangiopathy (TA-TMA)

This observational study aims to understand how often Transplant Associated Thrombotic Microangiopathy (TA-TMA), a known complication, occurs in adults who receive an allogeneic stem cell transplant (SCT). Researchers want to find out the incidence of TA-TMA and how it affects survival and other patient outcomes. You may be eligible if you are an adult (age 18 or older) undergoing an allogeneic SCT at UAB and are considered at high risk for TA-TMA, for example, if your BMI is over 35. The study involves collecting biological samples and following your standard clinical care. This study does not test any new drugs or interventions; it focuses on gathering information about TA-TMA.

Study design
This is an observational study with a planned enrollment of 85 adult participants. It is not testing a specific intervention but rather observing patients at high risk for TA-TMA.
What's involved
You would have biological samples collected according to a study schedule, starting before your stem cell transplant. You will also have standard clinical follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until 1 year after their stem cell transplant to assess outcomes.

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NCT07381205

Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)

Not Yet Recruiting
Not specifiedAges 18+Observational
Manuel Ricardo Espinoza-Gutarra
~85 participants
Updated 2026-07-06 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Objectives
Measured over From enrollment until 1 year post SCT
+1 more outcome measured

Conditions

Transplant Associated Microangiopathy TAM
Transplant Complication

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Acute Lymphoblastic LeukemiaAllogeneic Stem Cell TransplantationGraft Versus Host DiseaseSevere Aplastic AnemiaSickle Cell DiseaseTransplant Associated Thrombotic Microangiopathy

Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Manuel R Espinoza Gutarra, M.D.
[email protected]
205-975-2576
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\*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

What this trial measures

  • Primary ObjectivesFrom 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 ObjectiveFrom 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