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

NCT00744081 | Completed Phase 2

• 1 other identifier: AMLSG-R1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

AML

Outcome Measures

Primary Outcomes (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.

Interventions

Glivec DRUG

Mitoxantrone DRUG

Topotecan DRUG

AraC DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

University of Frankfurt, Medical Dept. II

Frankfurt, Germany

Location

Related Links

• (German Leukemia Trial Registry)

MeSH Terms

Interventions

Imatinib Mesylate; Mitoxantrone; Topotecan

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Quinones; Polycyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Lothar Bergmann, MD, PhD

  University Hospital of Frankfurt, Medical Dept. II

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: July 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

DE (1)