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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.
Must not have
Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) including: MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5), Therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Participant has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation.
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
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
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.
Select...
I have had a stem cell or organ transplant.
Select...
I have been treated with a BH3 mimetic before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC[0 to infinity] for azacitidine
AUC[0-24] for venetoclax
AUCt for Azacitidine
+9 more
Secondary study objectives
Duration of
Duration of CR
Duration of mOR
+15 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Venetoclax
2019
Completed Phase 3
~2240
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,450 Total Patients Enrolled
1 Trials studying MDS
55 Patients Enrolled for MDS
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,927 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,235 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,490 Total Patients Enrolled

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02942290 — Phase 1
MDS Research Study Groups: Venetoclax + Azacitidine
MDS 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
~26 spots leftby Jan 2027
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