Tokyo, March 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061017) titled 'Prospective study of immune escape clones in aplastic anemia' on March 23.

Study Type: Observational

Primary Sponsor: Institute - Kanazawa University

Condition: Condition - Aplastic anemia Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To determine whether the presence and longitudinal dynamics of HLA class I allele-deficient blood cells and PNH-type blood cells are associated with hematologic recovery (complete response) and clinical outcomes in patients with aplastic anemia. Basic objectives2 - Others

Eligibility: Age-lower limit - 2 years-old =6 months prior to enrollment with immunosuppressive agents (e.g., cyclosporine) or thrombopoietin receptor agonists 3. History of chemotherapy or radiotherapy within the past 5 years 4. Presence of cytogenetic abnormalities specific to hematologic malignancies, including complex karyotype, -7, 7q-, or der(1;7), on bone marrow cytogenetic analysis 5. Increased blasts, defined as persistent >=1% in peripheral blood or >=5% in bone marrow 6. Normocellular to hypercellular megakaryopoiesis observed in either bone marrow smear or biopsy 7. No elevation of serum thrombopoietin levels (only in patients in whom this was measured) 8. History of cytopenia for >=2 years prior to enrollment (defined as neutrophil count <1,500/uL [or white blood cell count <3,000/uL], hemoglobin <11 g/dL, or platelet count <150,000/uL), unless attributable to a clearly benign cause such as iron deficiency anemia 9. Secondary bone marrow failure syndromes (e.g., bone marrow carcinomatosis, myelofibrosis, hemophagocytic syndrome, systemic lupus erythematosus, drug-induced agranulocytosis) 10. Inherited bone marrow failure syndromes (including suspected cases) 11. Concomitant hematologic malignancies (hypoplastic myelodysplastic syndrome is not excluded unless the above criteria are met) 12. Concomitant solid tumors or autoimmune diseases requiring systemic treatment 13. Uncontrolled infections refractory to antimicrobial therapy 14. Life expectancy of <1 year due to comorbidities other than aplastic anemia 15. Inability to attend regular follow-up visits at a hematology outpatient clinic Target Size - 500

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 09 Month 30 Day Date of IRB - 2024 Year 10 Month 15 Day Anticipated trial start date - 2024 Year 10 Month 15 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069824

Disclaimer: Curated by HT Syndication.