IRB #

STUDY00019339

Title

Phase III Multicenter Open-Label Randomized Trial to Evaluate
Efficacy and Safety of CPI-613 in Combination with High Dose
Cytarabine and Mitoxantrone (CHAM) Compared to High Dose
Cytarabine and Mitoxantrone (HAM) in Older Patients (≥ 60 years)
with Relapsed/Refractory Acute Myeloid Leukemia (AML)

Principal Investigator

Rachel Cook

Study Purpose

This study is being done to answer the following question:

Is CPI-613, when given along with two other FDA-approved standard chemotherapy medications (Cytarabine and Mitoxantrone), a better treatment for relapsed/refractory Acute Myeloid Leukemia (AML) than Cytarabine and Mitoxantrone given without CPI-613? Also, does CPI-613 influence the duration of AML-free period for any patients that get better after receiving the combination of CPI-613 plus Cytarabine and Mitoxantrone?

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your AML. The usual approach is defined as care most people get for AML.

In this study, we will learn about a drug called CPI-613. CPI-613 will be called “the study drug”. We do not know if the study drug works. The study drug has not been approved by the Food and Drug Administration (FDA).

Medical Condition(s)

Acute Myeloid Leukemia (AML)

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 60 years or older,
-Have been diagnosed with AML and,
-After treatment, your disease has either relapsed (come back) or is refractory (has not responded to treatment)

Age Range

60 - n/a

Healthy Volunteers Needed

No

Duration of Participation

Total duration of participation can be up to 2 years. This includes a follow up of up to 12 months.

Minors Included

No

Contact

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

Sponsor

Rafael Pharmaceuticals, Inc.

Recruitment End

01/31/2028

Compensation Provided

No


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