We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00744081
Recruitment Status : Unknown
Verified August 2008 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
First Posted : August 29, 2008
Last Update Posted : August 29, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
AML Drug: Glivec Drug: Mitoxantrone Drug: Topotecan Drug: AraC Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : July 2004
Estimated Primary Completion Date : December 2007


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744081


Contacts
Contact: Lothar Bergmann, MD, PhD L.Bergmann@em.uni-frankfurt.de

Locations
Germany
University of Frankfurt, Medical Dept. II Recruiting
Frankfurt, Germany
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Lothar Bergmann, MD, PhD University Hospital of Frankfurt, Medical Dept. II
More Information

Additional Information:
Responsible Party: Prof. Dr. Lothar Bergmann, J. W. Goethe University
ClinicalTrials.gov Identifier: NCT00744081     History of Changes
Other Study ID Numbers: AMLSG-R1
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: August 29, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Imatinib Mesylate
Topotecan
Mitoxantrone
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Topoisomerase II Inhibitors