German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Deutsche Krebshilfe e.V., Bonn (Germany)

German Federal Ministry of Education and Research

Information provided by:

Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT00198991

First received: September 12, 2005

Last updated: May 29, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

May 29, 2008

Start Date ^ICMJE

April 2003

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Remission rate, Remission duration, Disease free survival,Overall survival

Original Primary Outcome Measures ^ICMJE

- Disease free survival
- Remission rate
- Remission duration
- Overall survival

Change History

Complete list of historical versions of study NCT00198991 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time and dose compliance, Realisation of SCT, Toxicity according to WHO, Course of MRD

Original Secondary Outcome Measures ^ICMJE

- Time and dose compliance
- Realisation of SCT
- Toxicity according to WHO
- Course of MRD

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

Official Title ^ICMJE

German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)

Brief Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Adult Acute Lymphocytic Leukemia

Intervention ^ICMJE

Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Vincristine
Drug: daunorubicin
Drug: Asparaginase
Drug: Methotrexate
Drug: Cytarabine
Drug: Mercaptopurine
Drug: G-CSF
Drug: Vindesine
Drug: VP16
Drug: Prednisolone
Drug: Adriamycin
Drug: Thioguanine
Drug: VM26
Procedure: CNS irradiation
Procedure: Mediastinal Irradiation
Procedure: Stem cell transplantation
Drug: Idarubicin
Drug: Fludarabine
Drug: Cladribine

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1250

Completion Date

Not Provided

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
Written informed consent

Exclusion Criteria:

Severe comorbidity or leukemia associated complications
Late relapse of pediatric ALL or ALL as second malignancy
Cytostatic pre-treatment
Pregnancy
Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
Participation in other clinical trials interfering with the study therapy

Gender

Both

Ages

15 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dieter Hoelzer, MD, PhD	++49 (0)69 6301 5194	hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD	++49(0)69 6301 6365	goekbuget@em.uni-frankfurt.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00198991

Other Study ID Numbers ^ICMJE

GMALL01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Deutsche Krebshilfe e.V., Bonn (Germany)
German Federal Ministry of Education and Research

Investigators ^ICMJE

Study Chair:

Dieter Hoelzer, MD,PhD

University Hospital of Frankfurt, Medical Dept. II

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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