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Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia

NCT00611247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-06-15

Study results available
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Summary

Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis

Conditions

  • Leukemia, Myeloid

Interventions

DRUG

Temozolomide

Priming, Group 2 only, 100 mg/m2/day temozolomide. Induction (both arms) 200 mg/m2/day temozolomide

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Bruno C. Medeiros

    lead OTHER

Principal Investigators

  • Bruno Carneiro de Medeiros · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-12-31
Completion
2010-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00611247 on ClinicalTrials.gov