BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia
| 対象疾患 | Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy, Secondary Acute Myeloid Leukemia |
|---|---|
| 相 | 第2相 |
| スポンサー | National Cancer Institute (NCI) |
| ステータス | 実施中（募集終了） |
| 参加者数 | 60 名 |
| 介入（薬剤） | Azacitidine, Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy |
| 開始日 | 2021年2月16日 |
| 完了日 | 2023年6月5日 |
| 結果公開日 | 2025年3月13日 |
概要
This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine and venetoclax with pembrolizumab may increase the rate of deeper/better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.
Percentage of Patients With Minimal Residual Disease Negative Complete Remission (MRD-CR) or MRD-complete Remission With Incomplete Count Recovery (Cri) With Azacitidine (AZA) + Venetoclax (VEN) With MK-3475 (Pembrolizumab)
| Arm I (AZA, VEN) | 13 Participants |
|---|---|
| Arm II (AZA, VEN, Pembrolizumab) | 13 Participants |
| Arm I (AZA, VEN) | 7 Participants |
| Arm II (AZA, VEN, Pembrolizumab) | 7 Participants |
| Arm I (AZA, VEN) | 9 Participants |
| Arm II (AZA, VEN, Pembrolizumab) | 9 Participants |
BENITIONS で見る ClinicalTrials.gov の原文を見る
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