Back to resultsImatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
Primary Purpose
AML
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Glivec
Mitoxantrone
Topotecan
AraC
Sponsored by
About this trial
This is an interventional treatment trial for AML
Eligibility 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
Sites / Locations
- University of Frankfurt, Medical Dept. II
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00744081
Brief Title
Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glivec
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Type
Drug
Intervention Name(s)
AraC
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lothar Bergmann, MD, PhD
Organizational Affiliation
University Hospital of Frankfurt, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
University of Frankfurt, Medical Dept. II
City
Frankfurt
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.leukemia-trials.eu
Description
(European Leukemia Trial Registry)
Learn more about this trial
Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
We'll reach out to this number within 24 hrs