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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johann Wolfgang Goethe University Hospital
• Treatments: Imatinib Mesylate; Mitoxantrone; Topotecan

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