Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase IV	Treatment	Active	15 to 65	Other	GMALL01 NCT00198991

Trial Description

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Klinikum der J.W. Goethe Universitaet

Dieter Hoelzer

Study Chair

Dieter Hoelzer, MD, PhD		Ph: ++49 (0)69 6301 5194
		Email: hoelzer@em.uni-frankfurt.de

Nicola Goekbuget, MD		Ph: ++49(0)69 6301 6365
		Email: goekbuget@em.uni-frankfurt.de

Germany
	Frankfurt
	Universitaetsfrauenklinik Frankfurt
		Dieter Hoelzer, MD,PhD	Ph: ++49(0)69 6301 5194
			Email: hoelzer@em.uni-frankfurt.de
		Nicola Goekbuget, MD	Ph: ++49(0)69 6301 6365
			Email: goekbuget@em.uni-frankfurt.de
		Dieter Hoelzer, MD,PhD	Principal Investigator
		Nicola Goekbuget, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00198991
Information obtained from ClinicalTrials.gov on March 24, 2009