Treatment (venetoclax, azacitidine) for Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Syndrome+5 More
Venetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial studies the effect of venetoclax and azacitidine in treating patients with therapy related or secondary myelodysplastic syndrome. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax in combination with azacitidine may work better in treating patients with therapy related or secondary myelodysplastic syndrome.

Eligible Conditions

  • Syndrome
  • Secondary Myelodysplastic Syndromes
  • Therapy-Related Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Syndrome

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: From earliest occurrence of PR, mCR, or CR to onset of progressive disease, assessed up to 24 months

Month 12
Percentage of participants who proceed to allogeneic hematopoietic stem cell transplantation
Day 28
Complete remission (CR)
Day 28
Biometric measures recorded by the FitBit (e.g., heart rate, number of steps taken, activity time, calories burned)
Day 28
Cytogenetic response rate (CCyR)
Hematologic improvement rate (HIR)
Overall response rate (ORR)
Rates of hematologic improvement-erythrocytes (HI-E)
Rates of hematologic improvement-neutrophils (HI-N)
Rates of hematologic improvement-platelets (HI-P)
Month 24
Percentage of participants who have disease that transforms to acute myeloid leukemia (AML)
Month 24
Overall survival (OS)
Month 24
Duration of response (DOR)
Month 24
Event free survival (EFS)
Month 12
Patient-reported outcomes (PROs)
Month 12
Detection of cytogenetic abnormalities
Day 30
Treatment emergent adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Syndrome

Trial Design

1 Treatment Group

Treatment (venetoclax, azacitidine)
1 of 1
Experimental Treatment

53 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (venetoclax, azacitidine) · No Placebo Group · Phase 2

Treatment (venetoclax, azacitidine)Experimental Group · 4 Interventions: Venetoclax, Azacitidine, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1670
Azacitidine
2012
Completed Phase 3
~1680

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from earliest occurrence of pr, mcr, or cr to onset of progressive disease, assessed up to 24 months
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus  1Photo of Columbus  2Photo of Columbus  3
2011First Recorded Clinical Trial
14 TrialsResearching Syndrome
202 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to understand the nature and purpose of the study and the procedures involved.
You have a performance status of 2 or less.
You have previously untreated therapy-related myelodysplastic syndrome (t-MDS) with IPSS-R risk categories Intermediate, High or Very High (i.e., minimum IPSS-R score of 3.
You have had prior therapy for cancer.
You have ALT < 3.0 x ULN x ULN.
Total bilirubin =< 2 x ULN.
Creatinine clearance > 30 mL/min or serum creatinine < 1.5 x the ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.