A Study Evaluating Venetoclax in Combination With Azacitidine Compared With Azacitidine Alone in Participants With Higher-Risk Myelodysplastic Syndromes (MDS) After Hypomethylating Agent-Failure
Summary
This is a Phase 1b, dose-ranging, open-label, multicenter study designed to evaluate the safety, pharmacokinetics, and efficacy of venetoclax as a single-agent and in combination with azacitidine in participants with higher-risk Myelodysplastic Syndromes (MDS) after Hypomethylating Agent (HMA)-Failure.
Description
Interventional study design - primary objective: Assess the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Myelodysplastic Syndromes (MDS)
Intervention
venetoclax, azacitidine
Status
Not yet recruiting
Source
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02966782
- ClinicalTrials.gov processed this data on November 17, 2016
Published on BioPortfolio: 2016-11-18T12:53:21-0500
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Medical and Biotech [MESH] Definitions
Myelodysplastic-myeloproliferative Diseases
Clonal myeloid disorders that possess both dysplastic and proliferative features but are not properly classified as either MYELODYSPLASTIC SYNDROMES or MYELOPROLIFERATIVE DISORDERS.
Hematopoietic Cell Growth Factors
These growth factors comprise a family of hematopoietic regulators with biological specificities defined by their ability to support proliferation and differentiation of blood cells of different lineages. ERYTHROPOIETIN and the COLONY-STIMULATING FACTORS belong to this family. Some of these factors have been studied and used in the treatment of chemotherapy-induced neutropenia, myelodysplastic syndromes, and bone marrow failure syndromes.
Myelodysplastic Syndromes
Clonal hematopoietic stem cell disorders characterized by dysplasia in one or more hematopoietic cell lineages. They predominantly affect patients over 60, are considered preleukemic conditions, and have high probability of transformation into ACUTE MYELOID LEUKEMIA.
Hematologic Neoplasms
Neoplasms located in the blood and blood-forming tissue (the bone marrow and lymphatic tissue). The commonest forms are the various types of LEUKEMIA, of LYMPHOMA, and of the progressive, life-threatening forms of the MYELODYSPLASTIC SYNDROMES.
Azacitidine
A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.
