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 Over 15 Other GMALL05 NCT00199082

Trial Description

Summary

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Eligibility Criteria

Inclusion Criteria:

• Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma

• Age > 15 years

• Written informed consent

Exclusion Criteria:

• Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected

• HIV infection

• Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy

• Known severe allergy to foreign proteins

• Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.

• Pregnancy or nursing

• Participation in other studies that interfere with 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 NCT00199082
Information obtained from ClinicalTrials.gov on July 16, 2008