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DNA Methyltransferase Inhibitor

Venetoclax + Azacitidine for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
Participant must have documented diagnosis of untreated de novo MDS with: International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of > 3) and Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from the first dose of study drug to start of new non-protocol specified mds therapy, and for up to 5 years after the last participant is enrolled.
Awards & highlights

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.

Who is the study for?
This trial is for adults with newly diagnosed higher-risk Myelodysplastic Syndromes (MDS) who haven't been treated before. They should have a certain level of risk based on scoring systems like IPSS or IPSS-R and less than 20% bone marrow blasts. Participants need to be fairly active and able to care for themselves (ECOG score ≤2). Those who've had previous MDS treatments, live vaccines recently, other types of MDS, or any organ transplants can't join.Check my eligibility
What is being tested?
The study tests Venetoclax combined with Azacitidine in people with high-risk MDS who haven’t received treatment yet. It's an early-phase trial that includes finding the right dose and checking how safe it is over time.See study design
What are the potential side effects?
Venetoclax and Azacitidine might cause side effects such as nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, and possibly liver issues. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have a specific type of blood disorder (MDS) that is serious but not yet treated, and my bone marrow is mostly healthy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from the date of first dose of study drug to the date of death, and for up to 5 years after the last participant is enrolled.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from the date of first dose of study drug to the date of death, and for up to 5 years after the last participant is enrolled. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC[0 to infinity] for azacitidine
AUC[0-24] for venetoclax
AUCt for Azacitidine
+9 more
Secondary outcome measures
Duration of CR
Duration of ORR
Duration of mORR
+15 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax + AzacitidineExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
946 Previous Clinical Trials
496,346 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,551 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
387 Previous Clinical Trials
141,027 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02942290 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Venetoclax + Azacitidine
Myelodysplastic Syndrome Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT02942290 — Phase 1
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02942290 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~3 spots leftby Jun 2024