Study Details

Open

A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation

This study will help us learn more about a newly discovered oral drug, DSP-5336, that is being tested in people with AML, ALL or acute leukemia of ambiguous lineage. DSP-5336 is a drug that interferes with a protein (Menin) in the body that has been found to have a role in developing leukemia. A drug that works by the mechanism is to interfere with a gene or protein that can develop cancer or leukemia are referred to as "molecularly targeted therapies." This is the first time this drug will be used in humans, so the study treatment has not yet been proven to be safe and/or effective for the treatment of AML, ALL or acute leukemia of ambiguous lineage. Participating in the study may not help you, but the information we get from this study may help improve the future treatment of people with AML, ALL or acute leukemia

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

At ech visit you will meet with a member of the study team, you will have a physical examination, blood draws, vital signs, 12 lead EKG, Chest x-ray and questions about your health.

Incentives

$75 stipend for each completed visit, $40 mileage reimbursed if you travel more than 25 miles one way to the hospital, $200 reimbursement for lodging if you travel more than 25 miles one way to the hospital, Study Medication

In-person visits:
8+

Total length of participation:
50

Looking for Specific Volunteers

Able to participate:

You have a diagnosis of Acute Meyloid Leukemia or Acute Lymphoblastic Leukemia
You are 18 or older
You have adequate Kidney and Liver Function
You are not pregnant

Not eligible if:

You have severe complications of Leukemia
You have had other investigational treatment within past 42 day
You have had major surgery within past 28 days
You have active central nervous system Leukem
You have abnormal EKG

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Joshua Zeidner
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia)

IRB Number

22-1262

ClinicalTrials.gov

NCT04988555