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

NCT ID: NCT00744081

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

AML

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glivec

Intervention Type DRUG

Mitoxantrone

Intervention Type DRUG

Topotecan

Intervention Type DRUG

AraC

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Goethe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lothar Bergmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lothar Bergmann, MD, PhD

Role: STUDY_CHAIR

University Hospital of Frankfurt, Medical Dept. II

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Frankfurt, Medical Dept. II

Frankfurt, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

http://www.studienregister-online.de

(German Leukemia Trial Registry)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMLSG-R1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.