IRB #

STUDY00021154

Title

[WIRB- IAA] Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant
TP53 and/or Complex Karyotype in Patients with Untreated
Acute Myeloid Leukemia ≥ Age 60 years

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to determine the safety and acceptability of the experimental drug, TP-0903 with Decitabine.

Medical Condition(s)

Acute Myeloid Leukemia (AML)

Eligibility Criteria

-Participating in the Beat AML umbrella study master protocol (reference IRB# 16475)
-Newly diagnosed with AML
-Age 60 years or older at time of diagnosis
-TP53 mutation and/or Complex Karyotype (defined as 3 or more abnormalities)

Age Range

60 - n/a

Healthy Volunteers Needed

No

Duration of Participation

A cycle is defined as 28 days. If CRMRD-/CR/CRh/CRi/MLFS is not obtained by completion of cycle 3 of induction therapy, patients will go off study treatment.

Maintenance is 2 years of therapy, up to 23 cycles of maintenance and up to 24 cycles of total treatment.

Trial-based therapies will be administered as above, until the conclusion of the study, unless relapse, death, or intolerable toxicity takes place, at which point treatment will cease. Patients discontinued from therapy for unacceptable adverse events will be followed until resolution or stabilization of the adverse event. Also, regardless, all participants will be followed for 30 days after removal from study treatment. Patients discontinued from therapy will also be followed every 3 months for life for survival, relapse, and other outcomes. If patients are unable to visit the site, the follow-up visit can be conducted by phone or electronic contact with the patient or authorized representative. This is only relevant for the survival follow up.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Beat AML, LLC, a division of the Leukemia and Lymphoma Society, Inc

Supported by: Tolero Pharmaceuticals, Inc.

Recruitment End

01/01/2038

Compensation Provided

No


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