A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation

UVA Tracking #
301112
Principal Investigator
Firas El Chaer
Contact
Contact Phone
Official Trial Title
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP 5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation
Study Description

The University of Virginia is participating in a clinical research study for adults ages 18 and over, who have you have a certain type of leukemia called acute leukemia (AML). This study will help us learn more about an investigational oral drug, DSP-5336, which is being tested in people with acute leukemia. The main purpose of this study is to evaluate how safe DSP-5336 is at different doses and to find a recommended dose for further study.

If you are enrolled and on treatment, you may continue participating in the study for as long as you and your doctor believe that the study drug is helping you. You can stay on treatment if your illness is not getting worse and if you are not having serious side effects or side effects that you cannot tolerate.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/study/NCT04988555
uvacancertrials@hscmail.mcc.virginia.edu

The (department, division name) seeks (insert as applies: adults/men/women/adolescents/children) ages (insert) with (insert condition) for a research study. The purpose of the study is (insert purpose of study - eg.to test the effectiveness of an investigational medicine; or to find out how stress effects blood pressure.)

(Optional)You may be eligible for this study if: (insert brief eligibility criteria 3 or 4 top criteria and in lay language. Do not copy eligibility criteria from the protocol)

Study involves (insert procedures-examples: taking an experimental medicine/placebo, blood draws, x rays, overnight stays,) (Insert x number of visits every x (weeks, months,) each visit lasting x amount of time or give range).

Insert one of the following:
Study-related (insert exams, tests and experimental medication) provided at no cost.
or
Participant’s insurance company will be billed for medication, test,s and procedures

Compensation

No Compensation