A Phase II Study of Cladribine, Cytarabine, Etoposide, and Venetoclax with Reduced Dose Conditioning Using Fludarabine, Busulfan, Melphalan, or Total Marrow Irradiation for Refractory Acute Myeloid Leukemia

What this Trial Is About

Refractory acute myeloid leukemia (AML) is a serious condition with few effective treatments. Researchers are evaluating a modified treatment protocol combining chemotherapy drugs cladribine, cytarabine, etoposide, and venetoclax followed by a reduced intensity conditioning (RIC) regimen. This phase II study aims to assess the feasibility and effectiveness of this approach to improve disease-free survival and reduce toxic side effects compared to previous treatments. The treatment involves a sequence starting with reduced doses of chemotherapy drugs cladribine, cytarabine, etoposide, and venetoclax administered over specific days before transplantation. This is followed by a conditioning regimen using fludarabine, busulfan, and melphalan or total marrow irradiation for patients who cannot receive busulfan or melphalan. The conditioning prepares the body for allogeneic stem cell transplantation, which occurs on day 0. Adjustments to the conditioning schedule can be made in cases of infection or donor availability. Participants will be monitored closely throughout the study, including assessments for disease remission and survival outcomes up to two years after treatment. Researchers will evaluate disease-free survival as the primary outcome at two years, along with secondary outcomes such as complete remission by day 60, overall survival, relapse rates, and non-relapse mortality at various time points. Safety and feasibility will also be observed to determine the treatment's potential benefit and risks. The total study duration spans from initial treatment through long-term follow-up.

Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia