Daunorubicin for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montefiore Einstein Cancer Center, Bronx, NY
Myelodysplastic Syndromes+5 More
Daunorubicin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the best dose and side effects of venetoclax when given with combination chemotherapy to treat patients with newly diagnosed acute myeloid leukemia or advanced myelodysplastic syndromes. Daunorubicin is used to treat Myelodysplastic Syndromes (MDS). Daunorubicin has previously been approved by the FDA for a different condition. This treatment is free for patients in this trial. No patients in this trial will receive a placebo.

Eligible Conditions

  • Myelodysplastic Syndromes
  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Through study completion, up to 6 years

Year 6
Duration of response
Year 6
Event-free survival
Frequency and severity of adverse events (AEs)
Hematologic response rate
Maximum tolerated dose of Venetoclax in combination with Daunorubicin and Cytarabine
Maximum tolerated dose of Venetoclax in combination with high dose cytarabine
Morphologic leukemia-free state
Overall response rate (ORR)
Overall survival
Rate of LSC eradication (exploratory objective)

Trial Safety

Safety Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Trial Design

1 Treatment Group

Venetoclax plus 7+3
1 of 1
Experimental Treatment

99 Total Participants · 1 Treatment Group

Primary Treatment: Daunorubicin · No Placebo Group · Phase 1

Venetoclax plus 7+3Experimental Group · 3 Interventions: Daunorubicin, Cytarabine, Venetoclax Oral Tablet · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
2013
Completed Phase 4
~4910
Cytarabine
2016
Completed Phase 3
~3090

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, up to 6 years
Closest Location: Montefiore Einstein Cancer Center · Bronx, NY
Photo of Bronx 1Photo of Bronx 2Photo of Bronx 3
2021First Recorded Clinical Trial
2 TrialsResearching Myelodysplastic Syndromes
5 CompletedClinical Trials

Who is running the clinical trial?

Ioannis MantzarisLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have adequate renal function.
You have a performance status of ≤2.
Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.

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.