SNDX-5613 for Leukemia, Myeloid, Acute

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Leukemia, Myeloid, Acute+3 More
SNDX-5613 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL). Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL

Eligible Conditions

  • Leukemia, Myeloid, Acute
  • Leukemia, Myelocytic, Acute

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Myeloid, Acute

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 1 year

Year 1
To establish the recommended phase II dose (RP2D) of SNDX-5613 in combination with oral decitabine/cedazuridine (ASTX727) and venetoclax for patients with acute myeloid leukemia (AML).

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Myeloid, Acute

Trial Design

3 Treatment Groups

Venetoclax
1 of 3
SNDX-5613
1 of 3
ASTX727
1 of 3
Experimental Treatment

43 Total Participants · 3 Treatment Groups

Primary Treatment: SNDX-5613 · No Placebo Group · Phase 1 & 2

Venetoclax
Drug
Experimental Group · 1 Intervention: Venetoclax · Intervention Types: Drug
SNDX-5613
Drug
Experimental Group · 1 Intervention: SNDX-5613 · Intervention Types: Drug
ASTX727
Drug
Experimental Group · 1 Intervention: ASTX727 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1670
ASTX727
2018
Completed Phase 3
~200

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
Closest Location: M D Anderson Cancer Center · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2003First Recorded Clinical Trial
93 TrialsResearching Leukemia, Myeloid, Acute
465 CompletedClinical Trials

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Industry Sponsor
92 Previous Clinical Trials
7,955 Total Patients Enrolled
15 Trials studying Leukemia, Myeloid, Acute
2,939 Patients Enrolled for Leukemia, Myeloid, Acute
Syndax Pharmaceuticals, Inc.UNKNOWN
3 Previous Clinical Trials
115 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,772 Previous Clinical Trials
1,795,169 Total Patients Enrolled
143 Trials studying Leukemia, Myeloid, Acute
10,837 Patients Enrolled for Leukemia, Myeloid, Acute
Ghayas Issa, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have relapsed/refractory AML or MPAL with a myeloid phenotype.
You have adequate renal function.

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.