Study of Bexarotene in Patients With Acute Myeloid Leukemia

Completed · Phase 1

Conditions studied: AML, Acute Myeloid Leukemia

In brief

Bexarotene may be useful in the treatment of Acute Myeloid Leukemia (AML). This is the first study on the use of bexarotene to treat patients with AML. The main purpose of this study is to establish the proper dose of bexarotene when used to treat AML. The side effect profile of bexarotene in patients with AML will also be explored.

Key facts

Study ID

NCT00316030

Run by

Abramson Cancer Center at Penn Medicine

People needed

54

Starts

2004-01-01

Last updated by the study team

2016-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years.
• Must have a histologically confirmed diagnosis of non-M3 AML as proven by bone marrow biopsy. Patients with CML in myeloid blast crisis are eligible.
• Willing and able to give informed consent.
• Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not be eligible for conventional chemotherapy
• ECOG performance status of 0-2
• Must have recovered from the toxicities of prior chemotherapy.
• Women of childbearing potential must use effective contraception after enrollment in this study and have a negative pregnancy test within 1 week of study enrollment. They must continue to use effective contraception for 3 months after stopping bexarotene.
• Men must agree to use effective methods of contraception while taking bexarotene and for 3 months after stopping therapy.

You may not qualify if…

• History of pancreatitis.
• Active alcohol abuse
• Taken bexarotene in the past.
• WBC >10,000/uL at the time of enrollment. Patients may be taking hydrea for WBC control at the time of enrollment.
• Cytotoxic chemotherapy or Mylotarg within the past 7 days other than hydrea.
• Significant organ dysfunction: total bilirubin>3x ULN, AST or ALT>3x ULN, creatinine>4mg/dL, on blood pressure supporting medications or mechanical ventilation.
• Serious medical or psychiatric conditions that may compromise the safety of the patient while participating in this study.
• Women of childbearing potential who are pregnant or actively breast feeding.
• Active participant in any other investigational treatment study for their AML.
• Unable/unwilling to perform required follow-up.
• Life expectancy of less than 1 month.
• Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation.
• Uncontrolled hyperlipidemia (triglycerides>1000 while on treatment with triglyceride lowering medications).
• History of myeloablative allogeneic stem cell transplant.
• Known history of HIV.
• Uncontrolled active infection
• Known active CNS involvement with AML

Where it is running

• Abramson Cancer Center of University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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