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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00744081
First received: August 28, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention Phase
AML
 Drug: Glivec
Drug: Mitoxantrone
Drug: Topotecan
Drug: AraC
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: July 2004
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
Investigators
Study Chair: Lothar Bergmann, MD, PhD University Hospital of Frankfurt, Medical Dept. II
  More Information

Additional Information:
(German Leukemia Trial Registry)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Dr. Lothar Bergmann, J. W. Goethe University
ClinicalTrials.gov Identifier: NCT00744081     History of Changes
Other Study ID Numbers: AMLSG-R1
Study First Received: August 28, 2008
Last Updated: August 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013