Study of Bexarotene in Patients With Acute Myeloid Leukemia

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Despite recent advances in cancer treatment, the prognosis is still poor for patients with relapsed or chemotherapy resistant AML. Further aggressive chemotherapy can be attempted, but generally yields poor results. This clinical study is the first use of bexarotene in the treatment of patient with relapsed or chemotherapy resistant AML. The main purpose of the study is to identify the maximum safe dose of bexarotene in patient with AML. Another objective of the study is to explore the side effect profile of bexarotene in AML patients. The study is organized so that the initial patients will get a low dose of bexarotene to be taken daily. If these patients tolerate the drug, then later patients will get higher daily doses. Further groups of patients will continue to increase their dose of bexarotene until a maximum tolerated dose is identified. The stu dy will end at that point. Patients will take the drug daily by mouth until such a time that their AML is worsening or they are experiencing unacceptable side effects. Their participating will end at that point. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00316030
Study type	Interventional
Source	Abramson Cancer Center of the University of Pennsylvania
Contact
Status	Completed
Phase	Phase 1
Start date	January 2004

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT04460235` - Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma	Phase 4
Completed	`NCT04022785` - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome	Phase 1
Completed	`NCT03678493` - A Study of FMT in Patients With AML Allo HSCT in Recipients	Phase 2
Recruiting	`NCT05424562` - A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
Completed	`NCT03197714` - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia	Phase 1
Terminated	`NCT03224819` - Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)	Early Phase 1
Active, not recruiting	`NCT04070768` - Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113	Phase 1
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Active, not recruiting	`NCT04107727` - Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)	Phase 2
Recruiting	`NCT04920500` - Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients	N/A
Recruiting	`NCT04385290` - Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)	Phase 1/Phase 2
Recruiting	`NCT03897127` - Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics	Phase 3
Active, not recruiting	`NCT04021368` - RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome	Phase 1
Recruiting	`NCT03665480` - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML	Phase 2/Phase 3
Completed	`NCT02485535` - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant	Phase 1
Enrolling by invitation	`NCT04093570` - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers	Phase 2
Recruiting	`NCT04069208` - IA14 Induction in Young Acute Myeloid Leukemia	Phase 2
Recruiting	`NCT05744739` - Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)	Phase 1
Recruiting	`NCT04969601` - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings	Phase 1/Phase 2