DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML

NCT02182596 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-07-08

No results posted yet for this study

Summary

For several years, the effective standard induction chemotherapy for AML has been limited to the association of anthracycline and aracytine. GO is the first effective targeted antibody used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated doses of GO used as a single agent for treatment of adult AML patients in first relapse. In the present study the possibility of combining fractionated doses of GO to escalated doses of a 3+7 regimen old is studied in relapsed AML patients \> 50 and \<70 years.

Conditions

Interventions

DRUG

Mylotarg

Dose level study

Sponsors & Collaborators

  • Acute Leukemia French Association

    lead OTHER

Principal Investigators

  • CASTAIGNE SYLVIE, PROFESSOR · Acute Leukemia French Association

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-09-30
Completion
2011-01-31

Countries

  • France

Study Locations

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Entities

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 NCT02182596 on ClinicalTrials.gov