Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leu... | NCT00744081

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

NCT00744081

Sponsor

Goethe University

Status

Completed

Last Update Posted

Mar 10, 2023Actual

Enrollment

130Estimated

Phase

Phase 2

Conditions

Interventions

Glivec
Mitoxantrone
Topotecan
AraC

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 28, 2008

First Submission Date that Met QC Criteria

Aug 28, 2008

First Posted Date

Aug 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2023

Last Update Posted Date

Mar 10, 2023Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lothar Bergmann, MD, PhD	University Hospital of Frankfurt, Medical Dept. II	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Frankfurt, Medical Dept. II		Frankfurt			Germany

Label	URL
(German Leukemia Trial Registry)	View source

Intervention Browse Module

MeSH Terms

ID	Term
D000068877	Imatinib Mesylate
D008942	Mitoxantrone
D019772	Topotecan

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Glivec	Drug
Mitoxantrone	Drug
Topotecan	Drug
AraC	Drug