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Hypomethylating Agent

Navitoclax + Venetoclax + Decitabine for Myelodysplastic Syndrome

Phase 1 & 2
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from enrollment of the last patient
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of navitoclax in combination with venetoclax and decitabine to treat patients with myelodysplastic syndrome that has come back or was not responsive to initial treatment.

Who is the study for?
Adults with aggressive myelodysplastic syndrome (MDS) who have tried azacitidine or decitabine and venetoclax without success. They must be able to swallow pills, not pregnant or breastfeeding, willing to use contraception, and have an ECOG Performance Status of 0-2 indicating they are relatively active.Check my eligibility
What is being tested?
The trial is testing the safety and optimal dose of navitoclax in combination with venetoclax and decitabine for MDS patients whose disease returned or didn't respond to initial treatment. It aims to assess how effective this drug combo is on patient health outcomes including quality of life.See study design
What are the potential side effects?
Potential side effects include issues from taking oral pills like stomach upset, risks associated with intravenous drugs such as infection at the injection site, plus general cancer treatment side effects like fatigue, nausea, low blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from enrollment of the last patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from enrollment of the last patient for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart rate
Decitabine
Secondary outcome measures
Change in quality of life (QOL) (Phase II)
Hematologic Improvement (HI) rate (Phase II)
Leukemia
+3 more
Other outcome measures
Apoptosis Inhibiting Proteins
Single cell gene expression (Phase II)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (navitoclax, decitabine, venetoclax)Experimental Treatment7 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Decitabine
2004
Completed Phase 3
~1680
Venetoclax
2019
Completed Phase 3
~1950
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Navitoclax
2012
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor
972 Previous Clinical Trials
506,088 Total Patients Enrolled
Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,650 Total Patients Enrolled
~10 spots leftby Jan 2025
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