NCT01550224

Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)

Temozolomide Plus Vorinostat in Patients With Relapse/Refractory Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Steven E. Coutre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.

Detailed description

The primary endpoint of the study is to determine the clinical efficacy as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat administered to 2 distinct groups of participants patients with AML and poor prognostic features. Participants will be allocated to treatment on the basis of O6-methylguanine DNA methyltransferase (MGMT) promoter methylation status.

Conditions

• Acute Myeloid Leukemia With 11q23-abnormality in Relapse

Interventions

Type	Name	Description
DRUG	Temozolomide	An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.
DRUG	Vorinostat	A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-11-17
• Completion: 2014-11-17
• First posted: 2012-03-09
• Last updated: 2018-08-09
• Results posted: 2018-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study