Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and Non-AML] for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Myelodysplastic Syndromes+10 More
Navitoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies. The names of the drugs involved in this study are: Venetoclax Decitabine Navitoclax

Eligible Conditions

  • Myelodysplastic Syndromes
  • Acute Myeloid Leukemia (AML)
  • Myeloproliferative Neoplasms (MPNs)
  • Agnogenic Myeloid Metaplasia
  • Myeloid Malignancy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: While on study treatment for up 1 year

Year 2
Median Progression-Free Survival (PFS)
Day 28
Objective Response Rate (ORR)
Year 2
Overall Survival (OS)
Day 28
Dose Limiting Toxicity (DLT)
Day 28
Recommended Phase 2 Dose (RP2D)
Year 1
Navitoclax Target Dose Rate

Trial Safety

Trial Design

5 Treatment Groups

Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and No...
1 of 5
Dose Level 2: Venetoclax + Decitabine + Navitoclax [AML]
1 of 5
Dose Level 0: Decitabine + Venetoclax + Navitoclax [AML and Non-AML]
1 of 5
Dose Level 1: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]
1 of 5
Dose Level -1: Venetoclax + Decitabine + Navitoclax [Non-AML]
1 of 5
Experimental Treatment

36 Total Participants · 5 Treatment Groups

Primary Treatment: Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and Non-AML] · No Placebo Group · Phase 1

Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]Experimental Group · 3 Interventions: Navitoclax, Venetoclax, Decitabine · Intervention Types: Drug, Drug, Drug
Dose Level 2: Venetoclax + Decitabine + Navitoclax [AML]Experimental Group · 3 Interventions: Navitoclax, Venetoclax, Decitabine · Intervention Types: Drug, Drug, Drug
Dose Level 0: Decitabine + Venetoclax + Navitoclax [AML and Non-AML]Experimental Group · 3 Interventions: Navitoclax, Venetoclax, Decitabine · Intervention Types: Drug, Drug, Drug
Dose Level 1: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]Experimental Group · 3 Interventions: Navitoclax, Venetoclax, Decitabine · Intervention Types: Drug, Drug, Drug
Dose Level -1: Venetoclax + Decitabine + Navitoclax [Non-AML]Experimental Group · 3 Interventions: Navitoclax, Venetoclax, Decitabine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
2012
Completed Phase 2
~90
Venetoclax
2019
Completed Phase 3
~1670
Decitabine
2004
Completed Phase 3
~1890

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: while on study treatment for up 1 year
Closest Location: Dana Farber Cancer Institute · Boston, MA
Photo of dana farber cancer institute  1Photo of dana farber cancer institute  2Photo of dana farber cancer institute  3
2004First Recorded Clinical Trial
37 TrialsResearching Myelodysplastic Syndromes
539 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years old.
You have myelofibrosis in accelerated phase.
You have a baseline platelet count of at least 25 x 109/L.
You have elevated aspartate transaminase (AST) and alanine transaminase (ALT) levels.
You have a bilirubin level of less than 1.5 times the upper limit of normal (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.