A Safety and Efficacy Study of Oral Venetoclax Tablets and Injectable Azacitidine Versus Best Supportive Care as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy to Evaluate Improveme
Summary
The main objective of this study is to evaluate safety and efficacy of venetoclax in combination with azacitidine (AZA) compared to best supportive care (BSC) as maintenance therapy in adult participants with acute myeloid leukemia (AML) in first remission after conventional chemotherapy. This study takes place in 2 parts evaluating improvement in relapse-free survival (RFS): Part 1 (Dose confirmation) and Part 2 (Randomization). Part 2 begins after safety is assessed in Part 1 for approximately 4 weeks. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month.
Study Design
Conditions
Acute Myeloid Leukemia (AML)
Intervention
Venetoclax, Azacitidine, Best Supportive Care (BSC)
Location
Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans
Louisiana
United States
70121
Status
Not yet recruiting
Source
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04102020
- ClinicalTrials.gov processed this data on September 27, 2019
Published on BioPortfolio: 2019-09-30T07:07:12-0400
Clinical Trials
This phase II trial studies how well venetoclax and azacitidine work for the treatment of acute myeloid leukemia after stem cell transplantation. Venetoclax, a BCL-2 inhibitor, and azaciti...
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best Supportiv...
This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute...
Azacitidine and Venetoclax in Treating Patients With High Risk Acute Myeloid Leukemia in Remission
This phase II trial studies how well azacitidine and venetoclax work in treating patients with high risk acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as az...
Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML
This study is being done to determine if treatment with azacitidine and venetoclax is effective treatment for elderly patients with acute myeloid leukemia (AML) who have not received previ...
PubMed Articles
Venetoclax is approved for older untreated acute myeloid leukemia (AML) patients. Venetoclax was available prior to approval off-label. We assessed our single-institution off-label experience with ven...
Acute myeloid leukemia (AML) is associated with poor outcomes, especially in older patients in whom the disease is most common. B-cell lymphoma 2 (BCL-2) is an antiapoptotic protein involved in the su...
Azacitidine is an hypomethylating agent widely adopted for the treatment of acute myeloid leukaemia (AML) in patients who are ineligible for curative-intent chemotherapy. Patients with low bone marrow...
Key paper evaluation: Craddock C, et al. Combination Lenalidomide and Azacitidine: A Novel Salvage Therapy in Patients Who Relapse After Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia...
Therapeutic Advances in First-Line Management of Acute Myeloid Leukemia.
Over the past several years, drug approvals for first-line treatment of acute myeloid leukemia have changed the landscape from a "wasteland" to an "embarrassment of riches." In general, patients deeme...
Medical and Biotech [MESH] Definitions
Leukemia, Myelomonocytic, Acute
A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.
Leukemia, Eosinophilic, Acute
A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.
Leukemia, Promyelocytic, Acute
An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.
Leukemia, Biphenotypic, Acute
An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.
Leukemia, Myeloid, Acute
Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.
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