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

Goethe University

Status and phase

Completed

Phase 2

Conditions

AML

Treatments

Drug: Mitoxantrone

Drug: Glivec

Drug: Topotecan

Drug: AraC

Study type

Interventional

Funder types

Other

Identifiers

NCT00744081

AMLSG-R1

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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