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

NCT01550224 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-08-09

Study results available
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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.

Conditions

  • Acute Myeloid Leukemia With 11q23-abnormality in Relapse

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Steven E Coutre, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-01
Primary Completion
2014-11-17
Completion
2014-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01550224 on ClinicalTrials.gov