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

AML Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744081
• Other study ID #: AMLSG-R1
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Est. completion date: December 2010

Study information

• Verified date: March 2023
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Glivec

• Mitoxantrone

• Topotecan

• AraC

Locations

Country	Name	City	State
Germany	University of Frankfurt, Medical Dept. II	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   (European Leukemia Trial Registry)