Stem Cell Transplant Complications Clinical Trial
Official title:
A Retrospective Observational Study of Adult and Pediatric Patients With Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplant (HSCT)
NCT number | NCT04970004 |
Other study ID # | ALX-TMA-501 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | July 12, 2021 |
Est. completion date | April 1, 2022 |
Verified date | May 2022 |
Source | Alexion Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational, retrospective study designed to assess outcomes in patients diagnosed with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who were not treated with complement component (C5) inhibitor therapy. Data required to evaluate study outcomes will be abstracted from the medical records of all patients who meet study eligibility criteria.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month and older |
Eligibility | Inclusion Criteria: - Body weight = 5 kg at the time of HSCT-TMA diagnosis - Documented TMA diagnosis within 6 months from the HSCT - Evidence of renal dysfunction - Presence of hypertension Exclusion Criteria: - History or presence of familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity < 5%) - Shiga toxin-related hemolytic uremic syndrome (ST-HUS) - Positive direct Coombs test - Diagnosis of disseminated intravascular coagulation - History or presence of bone marrow/graft failure - Diagnosis of veno-occlusive disease - Received a complement inhibitor (eg, eculizumab) post-HSCT through 12 months post TMA diagnosis |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Trial Site | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Alexion Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients achieving TMA Response | TMA Response is defined as platelet count = 50,000/mm^3, lactate dehydrogenase < 1.5 upper limit of normal, absence of schistocytes (if present at baseline), and increase in eGFR = 30% from baseline or discontinuation of dialysis (for patients on dialysis at baseline) | During the 26-week period after HSCT-TMA diagnosis | |
Secondary | Proportion of patients achieving TMA response | During the 52-week period after HSCT-TMA diagnosis | ||
Secondary | Changes in individual components of TMA response | Platelets, lactate dehydrogenase, eGFR, chronic kidney disease stage, dialysis status | From baseline to 26 weeks and to 52 weeks after HSCT-TMA diagnosis | |
Secondary | Overall survival | At 26 weeks and 52 weeks after HSCT-TMA diagnosis | ||
Secondary | Nonrelapse mortality | Death due to any cause during the study, with the exception of death due to underlying disease progression or relapse | At 26 weeks and 52 weeks after HSCT-TMA diagnosis |
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