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Completed

NCT Number: NCT00744081

Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.

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Key information

Conditions

AML

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Frankfurt, Medical Dept. II

Frankfurt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Refractory AML after primary therapy
  • First relapse after a safe previous diagnosis of de novo or secondary AML
  • Age > 18 years
  • Serum bilirubin < 2.0 mg/dl
  • Serum creatinine < 1.5 times the normal value or a creatinine clearance > 60 ml/min
  • ECG and heart echography prior to start of therapy without severe findings
  • Overall condition < 2 according to ECOG criteria
  • Life expectancy > 6 weeks
  • Written informed consent by patients with full legal capacity

Exclusion criteria

  • Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency)
  • Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma)
  • Known hypersensitivity to topoisomerase-I inhibitors
  • Overall condition > 2 according to ECOG criteria
  • Pregnant/breast feeding women
  • Serious intercurrent infections

Treatment and study plan

Glivec

Drug

Mitoxantrone

Drug

Topotecan

Drug

AraC

Drug

Primary outcomes

  1. To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Open-label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 29, 2008
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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