warm antibody autoimmune hemolytic anemia (wAIHA)
Conditions
Interventions
Test Group:all-trans retinoic acid + prednisone
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years. 2. Confirmed diagnosis of newly diagnosed warm antibody autoimmune hemolytic anemia (wAIHA) based on immunological test results and clinical evaluation. 3. Positive direct antiglobulin test (DAT), presenting as isolated anti-IgG positivity and/or anti-C3d positivity. 4. No prior history of any treatment related to wAIHA. 5. Hemoglobin level between 70–100 g/L. 6. Normal cardiac function and normal renal function (serum creatinine <= 1.0 × upper limit of normal). 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. Able and willing to provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with autoimmune hemolytic anemia (AIHA) types other than warm antibody autoimmune hemolytic anemia (wAIHA). 2. Secondary warm antibody autoimmune hemolytic anemia (wAIHA) caused by medications, lymphoproliferative disorders, infectious diseases, or active hematologic malignancies. Subjects with positive autoantibodies who do not meet the criteria for autoimmune diseases are permitted to participate. 3. Presence of contraindications to the use of the study drugs, including but not limited to those listed in the respective drug package inserts. (Patients with diabetes mellitus are excluded.); 4. Patients with known hypersensitivity to the active ingredients or excipients of the study drugs. 5. Current diagnosis of HIV infection, or hepatitis B virus or hepatitis C virus infection. 6. History of or concurrent malignancy. 7. Women who are pregnant, breastfeeding, or planning to become pregnant, as well as patients whose partners are planning to become pregnant. 8. Any other conditions that, in the investigator's opinion, may prevent the subject from completing this study or pose significant risks to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-week relapse-free survival (RFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 48-week RFS / relapse rate;Time to relapse at 24 weeks;Objective response rate (ORR) at weeks 12, 24, and 48;Proportion of subjects not receiving salvage therapy during the treatment period;Sustained hemoglobin response rate during week 24 and week 48;Change from baseline in QoL (FACIT-F) score at week 12; | — |
Countries
China
Contacts
Public ContactGuangsheng He
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed