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NCT00744081 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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.
See also
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Terminated NCT03761069 - Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias Phase 1
Completed NCT02631993 - Photochemotherapy and Graft-versus-leukemia in Acute-leukemia N/A
Completed NCT02575963 - Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients Phase 1/Phase 2
Completed NCT00780598 - Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML Phase 2
Completed NCT00863148 - Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL) Phase 2
Completed NCT00761449 - Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5 Phase 2
Completed NCT00542971 - Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006) Phase 1/Phase 2
Completed NCT00589082 - DaunoXome + Ara-C vs Daunorubicin + Ara-C in Elderly AML Phase 3

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