Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML) - Full Text View

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

This study is currently recruiting participants.
Verified by Johann Wolfgang Goethe University Hospitals, August 2008

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00744081

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 II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Cytarabine Cytarabine hydrochloride Mitoxantrone hydrochloride Mitoxantrone Topotecan hydrochloride Topotecan Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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)

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

(European Leukemia Trial Registry) This link exits the ClinicalTrials.gov site

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

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

Study placed in the following topic categories:

Imatinib

Leukemia

Acute myelogenous leukemia

Mitoxantrone

Leukemia, Myeloid

Topotecan

Leukemia, Myeloid, Acute

Acute myelocytic leukemia

Cytarabine

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

Neoplasms

Sensory System Agents

Therapeutic Uses

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 24, 2008