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

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00744081
• Collaborator: (none)
• Enrollment: 130
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AML	Drug: Glivec; Drug: Mitoxantrone; Drug: Topotecan; Drug: AraC	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jul 1, 2004
• Anticipated Primary Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Frankfurt, Medical Dept. II	Frankfurt		Germany

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Study Chair: Lothar Bergmann, MD, PhD, University Hospital of Frankfurt, Medical Dept. II

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (European Leukemia Trial Registry)

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00744081
• Other Study ID Numbers: AMLSG-R1
• First Posted: Aug 29, 2008
• Last Update Posted: Aug 29, 2008
• Last Verified: Aug 1, 2008

• Additional relevant MeSH terms: Leukemia, Myeloid, Acute; Topotecan; Mitoxantrone

Study Results

No Results Posted as of Aug 29, 2008