IRB #

STUDY00018809

Title

A Phase 1 Trial to Evaluate the Potential Impact of Renal
Impairment on the Pharmacokinetics and Safety of
CPX-351 (Daunorubicin and Cytarabine) Liposome for
Injection Treatment in Adult Patients with Hematologic
Malignancies

Principal Investigator

Laura Newell

Study Purpose

This study is being done to answer the following question:

Does reduced kidney function impact the pharmacokinetics (how the drug works in the body) of CPX-351 (study drug) in patients with hematologic malignancies (newly diagnosed or refractory or relapsed)?

The study drug is currently approved by the U.S. Food and Drug Administration for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

The hematologic malignancies that will be studied include but not limited to acute myeloid leukemia (AML), acute lymphocytic/lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS).

The Sponsor is doing this study to assess the potential impact of moderate and severe kidney function on the pharmacokinetics (PK) and safety of the study drug. The result from this study will help to guide the dose adjustment of the study drug for patients with moderate or severe kidney function, if necessary.

Medical Condition(s)

Acute Myeloid Leukemia (AML), Acute Lymphocytic/Lymphoblastic Leukemia (ALL), and Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Eligible subjects must meet the following:
-Be 18 years of age or older,
-Diagnosed with a hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory (has not responded) to initial treatment, or in relapse (disease came back).

Age Range

18 - N/A

Healthy Volunteers Needed

No

Duration of Participation

If you decide to take part in this study, the duration of study drug may vary from approximately 21 days to up to 224 days depending on the number of treatment cycles. After you finish the study drug treatment, your investigator will continue to watch you for side effects and follow your condition within 40 days after the last dose of study drug (safety follow-up).

Minors Included

No

Contact

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

Sponsor

Jazz Pharmaceuticals

Recruitment End

01/01/2028

Compensation Provided

No


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