Study Summary
This trial is testing the combination of venetoclax and azacitidine to see if it is effective and has manageable side effects in treating patients with high-risk myelodysplastic syndrome.
- Myelodysplastic Syndrome
- Chronic Myelomonocytic Leukemia
- Therapy-Related Myelodysplastic Syndrome
- Refractory Myelodysplastic Syndromes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 14 Secondary · Reporting Duration: Up to 5 years
Trial Safety
Safety Progress
Side Effects for
Trial Design
1 Treatment Group
Treatment (venetoclax, azacitidine)
1 of 1
Experimental Treatment
116 Total Participants · 1 Treatment Group
Primary Treatment: Venetoclax · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Bazinet, Alexandre, Faezeh Darbaniyan, Elias Jabbour, Guillermo Montalban-Bravo, Maro Ohanian, Kelly Chien, Tapan Kadia, et al.. 2022. “Azacitidine Plus Venetoclax in Patients with High-risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukaemia: Phase 1 Results of a Single-centre, Dose-escalation, Dose-expansion, Phase 1–2 Study”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(22)00216-2.
- Bazinet A, Darbaniyan F, Jabbour E, Montalban-Bravo G, Ohanian M, Chien K, Kadia T, Takahashi K, Masarova L, Short N, Alvarado Y, Yilmaz M, Ravandi F, Andreeff M, Kanagal-Shamanna R, Ganan-Gomez I, Colla S, Qiao W, Huang X, McCue D, Mirabella B, Kantarjian H, Garcia-Manero G. Azacitidine plus venetoclax in patients with high-risk myelodysplastic syndromes or chronic myelomonocytic leukaemia: phase 1 results of a single-centre, dose-escalation, dose-expansion, phase 1-2 study. Lancet Haematol. 2022 Oct;9(10):e756-e765. doi: 10.1016/S2352-3026(22)00216-2. Epub 2022 Sep 2.
- 2019. "Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04160052.
Frequently Asked Questions
Is this research currently enrolling participants?
"As per clinicaltrials.gov, this research project is presently recruiting participants. It was first posted on October 1st 2019 and last modified on June 8th 2022." - Anonymous Online Contributor
In what other capacities has Venetoclax been examined?
"At present, 340 Venetoclax trials are active with 54 in Phase 3. Toronto is one of the prime locations for these studies; however, there exist 11,189 clinical trial sites that conduct research on this medication." - Anonymous Online Contributor
How many individuals are currently participating in this trial's proceedings?
"Absolutely. The clinicaltrials.gov website attests to the fact that this trial is currently recruiting individuals, as it was initially posted on October 1st 2019 and recently updated on June 8th 2022. 116 patients are needed from one particular medical site for successful completion of the experiment." - Anonymous Online Contributor
To what maladies is Venetoclax typically prescribed as a remedy?
"Venetoclax is regularly used for induction chemotherapy, yet can also be beneficial in alleviating the symptoms associated with refractory anemias, leukemia, myelocytic and acute multilineage dysplasia." - Anonymous Online Contributor