Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Bexarotene

• Registration Number: NCT00615784
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-14
• Study Start: 2010-05-25
• Primary Completion: 2013-10-01
• Study Completion: 2013-11-08
• Disposition First Submitted: 2020-04-20
• Disposition First Submitted QC: 2020-04-20
• Disposition First Posted: 2020-04-24
• Results First Submitted: 2020-10-27
• Results First Submitted QC: 2020-10-27
• Status Verified: 2020-11
• Results First Posted: 2020-11-17
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age >= 18 years
• Confirmed diagnosis of AML as proven by bone marrow biopsy
• Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
• ECOG performance status of 0-2
• Recovered from toxicities of prior chemotherapy

Exclusion Criteria

• History of pancreatitis
• Active alcohol abuse
• Taken bexarotene in the past
• WBC > 10,000/uL at time of enrollment
• Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg
• Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN, creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
• Active participant in any other investigational treatment study for AML
• 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
• Known history of HIV
• Known active CNS involvement with AML
• Women of childbearing potential or active breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Bexarotene	-

Primary Outcome Measures

Name	Time	Method
Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.	Two months after 17th patient has started treatment with Bexarotene, for up to 1 year	Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674

Secondary Outcome Measures

Name	Time	Method
Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy	Two months after 17th patient has started treatment with Bexarotene, up to 1 year.	A clinically significant result will be recorded if the patient's bone marrow blasts percentage decreased by 50% or more over pretreatment blast percentage.

Trial Locations

Locations (1)

Abramson Cancer Center of University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States