Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leu
The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study
| Condition(s) | Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study |
| Who can participate | Inclusion Criteria: 1. Understand and voluntarily sign informed consent; 2. Age 18 and above; 3. Subjects with confirmed International Consensus Classification (ICC) relapsed/refractory acute myeloid leukemia (R/R-AML) : Recurrence was defined as the recurrence of leukemia cells in peripheral blood or ≥5% of bone marrow original cells after complete response (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or the occurrence of extramedullary leukemia cell infiltration. Refractory is defined as meeting any of the following criteria: 1. Initial treatment cases that failed after 2 courses of treatment with standard protocols; 2. Relapse within 12 months after complete remission (CR) after consolidation and intensive treatment; 3. Recurrence after 12 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Changzhou Qianhong Bio-pharma Co., Ltd. |
| Locations | Zhengzhou, Henan, China; Wuhan, Hubei, China; Changzhou, Jiangsu, China; Huaian, Jiangsu, China; Nanjing, Jiangsu, China; Nanjing, Jiangsu, China (+4 more sites) |
| Start date | 2023-08-10 |
| NCT ID | NCT06532058 |
| Official listing | https://clinicaltrials.gov/study/NCT06532058 |