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Clinical trialNCT02878785CompletedPhase 1/PHASE2Interventional

Decitabine and Talazoparib in Untreated AML and R/R AML

SponsorUniversity of Maryland, BaltimoreEnrollment25Acute Myeloid Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to find the best way to combine a new chemotherapy drug with one that is already in use to treat AML. The new experimental drug is called talazoparib (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA). The FDA is allowing the use of talazoparib for the purposes of this study. Decitabine is used to treat bone marrow diseases called myelodysplastic syndromes (MDS), as well as off label for AML. Lab work suggests that talazoparib will increase the effects of decitabine in leukemia cells. Investigators hope that treating patients with decitabine and talazoparib together will be more successful that treating patients with decitabine alone. This study has two parts. The purpose of part one the study is to find out the best doses of decitabine and talazoparib to use when they are given together to treat AML. The purpose of part two is to see how well the drugs work together to treat AML. All participants in the study will be treated with decitabine and talazoparib. Part one of the study will include as few as two people and as many as 36 people to find the best dose levels of the study drugs. Part one will begin enrolling first. Part two of the study will not start until the Part one of the study is complete. Participants will be told which part of the study they may be enrolled in. Part two of the study may include as few as 79 people and as many as 135 people. Part two includes three separate arms. Participants enrolled in Part two of the study, will be assigned to one of the three arms below in order to test the success rate of the study drug dose determined by Part one: * Arm A will enroll adult patients with AML who are thought not to be likely to tolerate or respond to standard chemotherapy; * Arm B will enroll adult patients with AML that has not responded to previous treatment or has come back after responding to previous treatment; * Arm C will enroll adult patients previously treated with a DNA methyltransferase inhibitor (decitabine, azacitidine or guadecitabine). This is a multi-center study. Up to 171 people may take part in this study globally.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DecitabineTalazoparib
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2016
Primary completion
5 Jan 2020
Completion
19 Nov 2020
Last update posted
29 Mar 2023
Registered enrollment
25
Registry id
NCT02878785

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.