Study of Patients With Thrombotic Microangiopathy Associated With Mitomycin C, Treated or Not With Eculizumab

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a serious condition called thrombotic microangiopathy (TMA) that can occur in patients who have received a chemotherapy drug called mitomycin C. TMA is a condition where the blood doesn't flow properly due to small blood clots, leading to symptoms like low blood platelets, anemia (low red blood cells), and damage to organs, especially the kidneys. The trial aims to learn more about how patients with TMA due to mitomycin C respond to treatment, particularly focusing on a medication called eculizumab, which has shown promise in other forms of TMA.

To be eligible for this study, participants must be adults aged 18 and older who have received mitomycin C at any time from 1990 to 2023 and have developed TMA symptoms related to this treatment. Participants can expect to undergo assessments that include clinical evaluations and tests to understand their condition better, regardless of whether they have received any treatment for TMA. The study is currently recruiting participants and aims to gather important information that could help improve care for patients facing this serious side effect of chemotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (\>=18 years)
• • Having received treatment with mitomycin C (regardless of the method of administration and indication) between 01/01/1990 and 12/31/2023
• * and having developed a picture of thrombotic microangiopathy attributed to mitomycin C:
• • biological: defined as: thrombocytopenia \<150G/L and mechanical hemolytic anemia (at least 3 out of 4 criteria: hemoglobin \< 12g/dL, presence of schistocytes in blood smear, LDH \> 1N, collapsed haptoglobin (\< lower limit of the limit of laboratory normal)
• • or renal: pathological diagnosis of thrombotic microangiopathy on renal biopsy
• • having received or not treatment for the episode of microangiopathy, including or not complement inhibitors (Eculizumab).
• • Subject not opposing, after information, the reuse of their data for the purposes of this research
• Exclusion Criteria:
• • Subject having expressed opposition to participating in the study
• • Test for positive Shiga toxin
• • ADAMST13 activity \<10%
• • Thrombotic microangiopathy attributed to metastatic cancer (infiltration of bone marrow or circulating erythroblasts)
• • Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
• • Subject under judicial protection
• • Subject under guardianship or curatorship