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Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab

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

GMALL03
NCT00199004

Trial Description

Summary

The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation

Eligibility Criteria

Inclusion Criteria:

B-precursor ALL (common / pre B-ALL)

Standard risk

CD20 expression >20%

Ph/BCR-ABL negative

Age 15-65 years (55-65 if biologically younger)

Written informed consent

Exclusion Criteria:

Severe complications due to leukemia or secondary illnesses

Late relapse of childhood ALL

Cytostatic pretreatment

Pregnancy

Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent

Known severe allergy to foreign proteins

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)696301 6365
		Email: goekbuget@em.uni-frankfurt.de

Trial Sites

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 NCT00199004
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.