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

NCT07381205 | Not Yet Recruiting DMC

• 1 other identifier: UAB2537
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Transplant Associated Microangiopathy TAM; Transplant Complication

Keywords

Transplant Associated Thrombotic Microangiopathy; Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  From enrollment until 1 year post SCT

Secondary Outcomes (4)

• Secondary Objectives

  From enrollment until 1 year post SCT

• Secondary Objective

  From enrollment until 1 year post SCT

• Secondary Objective

  From enrollment until 1 year post SCT

• Secondary Objective

  From enrollment until 1 year post SCT

Other Outcomes (4)

• Exploratory Objectives

  From enrollment until 1 year post SCT

• Exploratory Objective

  From enrollment until 1 year post SCT

• Exploratory Objective

  From enrollment until 1 year post SCT

Study Arms (3)

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 eculizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)\[18, 43\]
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manuel Ricardo Espinoza-Gutarra: lead
• BMS Foundation: collaborator
• Viracor Eurofins: collaborator

Study Sites (1)

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Bone Marrow Aspirate

Central Study Contacts

Manuel R Espinoza Gutarra, M.D.

CONTACT

205-975-2576; mgutarra@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)