Clinical Trials Logo

Clinical Trial Summary

Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04401748
Study type Interventional
Source AbbVie
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 10, 2020
Completion date September 10, 2025

See also
  Status Clinical Trial Phase
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Suspended NCT01211691 - Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF) Phase 1/Phase 2
Active, not recruiting NCT06294275 - A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects Phase 1
Completed NCT00533416 - Safety of ON 01910.Na in Patients With Myelodysplasia Phase 1
Recruiting NCT04608110 - A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome Phase 1
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Withdrawn NCT03486353 - A Study of FF-10501-01 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Terminated NCT01459159 - Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome Phase 2
Terminated NCT01422486 - Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome Phase 2
Terminated NCT00542828 - Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome Phase 2
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Recruiting NCT01861093 - Safety Study of Cord Blood Units for Stem Cell Transplants Phase 2
Unknown status NCT01983761 - Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01338337 - Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia Phase 2
Completed NCT01221857 - Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies Phase 1/Phase 2
Terminated NCT01034657 - LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS) Phase 2