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
| Condition | Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy, Secondary Acute Myeloid Leukemia |
|---|---|
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Status | Active, not recruiting |
| Enrollment | 60 participants |
| Interventions | Azacitidine, Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy |
| Start date | Feb 16, 2021 |
| Completion date | Jun 5, 2023 |
| Results posted | Mar 13, 2025 |
Summary
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 |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
- Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diag — National Cancer Institute (NCI)
- Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Tr — National Cancer Institute (NCI)
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibruti — National Cancer Institute (NCI)
- Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituxim — National Cancer Institute (NCI)
- Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute — Wake Forest University Health Sciences
- Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Ri — National Cancer Institute (NCI)