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Venetoclax + Azacitidine for Myelodysplastic Syndrome
Study Summary
This trial is testing a new cancer treatment combining venetoclax with azacitidine in people who have a specific type of blood cancer that has not been treated before. The aim is to find the best dose of the treatment and to see if it is safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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Who is running the clinical trial?
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- I can take care of myself and am up and about more than half of my waking hours.I have a specific type of blood disorder (MDS) that is serious but not yet treated, and my bone marrow is mostly healthy.My condition is a type of MDS not treated before, with a low to intermediate risk score, or it has evolved from another blood disorder.I have received treatment for myelodysplastic syndrome (MDS) before.I have had a stem cell or organ transplant.I have not received a live vaccine in the last 4 weeks.I have been treated with a BH3 mimetic before.
- Group 1: Venetoclax + Azacitidine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is enrollment in this research program still available?
"Unfortunately, recruitment for this trial has already concluded. The original posting date was December 1st 2017 and most recently updated on August 1st 2022. For those still looking to participate in a clinical study, there are currently 1596 different trials recruiting patients with myelodysplastic syndromes and 340 studies seeking individuals willing to partake in Venetoclax treatment."
What other trials have been conducted in conjunction with Venetoclax?
"At this moment, 340 clinical trials with Venetoclax as the primary intervention are in progress and 54 of them have reached phase 3. For anyone interested in participating, 11189 medical centres across the world offer studies with Venetoclax; a considerable selection is available in Edmonton, Alberta."
How widely is the trial being implemented across healthcare facilities?
"Currently, 17 different medical centres are enrolling for this trial. These sites stretch from Boston to Tucson and Pittsburgh with 14 additional locations in between. To reduce the amount of travelling necessary if accepted into the study, it is recommended that you select a clinic closest to your home location."
How many participants is this exploration seeking to recruit?
"Any further recruitment for this medical trial has ceased. The research was initially published on December 1st, 2017 and had its last update in August 2022. If you are interested in similar studies, note that there are 1596 trials actively recruiting patients with myelodysplastic syndromes and 340 clinical trials using Venetoclax as a treatment option currently open to participants."
To what effect is Venetoclax usually prescribed?
"Venetoclax is often employed in induction chemotherapy, as well as for treating refractory anaemias, leukaemia, myelocytic acute and multi-line dysplasia."
What goals have been identified for this trial's success?
"The primary objective of this clinical study is to assess the Clearance (CL) for azacitidine over 32 days. Secondary endpoints include Duration of Response (DOR), Complete Remission (CR) rate and Overall Response Rate (ORR). DOR is defined as the period between first response and progression or death, CR rate corresponds with International Working Group 2006 criteria for Myelodysplastic Syndromes, while ORR combines complete remission plus partial remission rates from venetoclax + azacitidine."
Has regulatory approval been granted for the use of Venetoclax?
"Since Venetoclax is currently in a Phase 1 trial, the safety rating for this medication was assessed as a 1 due to minimal data collected."
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