Acute myeloid leukemia (AML) is a heterogeneous blood cancer arising from clonal expansion of myeloid precursors in bone marrow, causing marrow failure and circulating blasts. It is also called acute myelogenous leukemia and requires rapid specialist treatment.
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
Omeros reported initial nonhuman primate data for OncotoX-AML in acute myeloid leukemia. One treatment course reduced myeloid progenitor cells by up to 99% and was well tolerated.
The FDA approved acalabrutinib combined with venetoclax for chronic lymphocytic leukemia and small lymphocytic leukemia based on phase III trial results. Separately, Yale researchers identified CD25 protein complex as a new drug target for aggressive leukemias.
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
West Virginia University Cancer Institute has dosed the first patient in a phase 1/2 trial evaluating subcutaneous blinatumomab for CD19-positive mixed-phenotype acute leukemia, a rare disease with no FDA-approved therapies. The first patient achieved complete remission after one cycle.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07587944 |
Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity |
RECRUITING | |
| NCT07539818 |
Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML |
NOT_YET_RECRUITING | PHASE3 |
| NCT07516353 |
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults |
NOT_YET_RECRUITING | NA |
| NCT07508982 |
Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07493538 |
MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases |
RECRUITING | PHASE2 |
| NCT07490288 |
Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML |
NOT_YET_RECRUITING | NA |
| NCT07347171 |
A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies |
RECRUITING | PHASE1 |
| NCT07342244 |
Safety and Efficacy of CLL1 CAR-T Followed by Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia |
NOT_YET_RECRUITING | NA |
| NCT07163728 |
Leptin: A Marker for AML Chemo-Sensitivity |
RECRUITING | |
| NCT07131085 |
QH101 Cell Therapy Relapsed/Refractory(R/R) Acute Myeloid Leukemia(AML) and Myelodysplastic Syndromes(MDS) |
NOT_YET_RECRUITING | PHASE1 |
