Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 to 65	Other	DSHNHL 2004-R4 DSHNHL 2004-R4, NCT00521560

Trial Description

Summary

Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma

Eligibility Criteria

Inclusion Criteria:

• Age: 18 - 65 years

• Risk group: 1) Progression on primary therapy 2) Initial or subsequent relapse

• Histology: Diagnosis of relapsed aggressive non-Hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. The expression of the CD20 antigen must be demonstrated in the primary lesion or in the relapse. Specifically, the following entities can be treated in this study:

B-NHL:

Grade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)

• General condition: General condition ECOG 0-3 (Karnofsky: 40 - 100 %); for definition see Annex 14.10

• Presence of declaration of participation of the center and the patient's written consent form

Exclusion Criteria:

• Prior mediastinal or extensive abdominal irradiation

• Prior high-dose therapy and autologous stem cell transplantation

• Impairment of renal function (creatinine > 2.5 mg/dL, creatinine clearance < 20 mL/min)

• Impairment of hepatic function (bilirubin > 2.0 mg/dL, cholinesterase [CHE] < 2000 U/L)

• Impairment of pulmonary function (transfer lung factor for CO [TLCO] < 50 %, forced expiratory volume in 1 sec [FEV1] < 60 %, vital capacity [VC] < 60 %)

• Relevant deterioration of the above organ functions on salvage therapy

• Failure of stem cell mobilization

• Active viral hepatitis

• HIV infection

• Other active or not conclusively curatively treated malignoma

• Severe concomitant psychiatric illness or suspected lack of patient compliance

• Pregnancy or unreliable contraception

• Highly dynamic progress of lymphoma (lactate dehydrogenase [LDH] > 1.5 x upper limit of normal [ULN]) after salvage therapy immediately prior to radioimmunotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH - Universitaetsklinikum Goettingen

Bertram Glass, Prof. Dr.

Study Director

Martin Gramatzki, MD PhD

Principal Investigator

Mattias Witzens Harig, MD PhD

Principal Investigator

Bernd Hertenstein, MD PhD

Principal Investigator

Georg Heß, MD PhD

Principal Investigator

Dorothea Kofahl-Krause, MD PhD

Principal Investigator

Norbert Schmitz, MD PhD

Principal Investigator

Jörg Schubert, MD PhD

Principal Investigator

Lutz Uharek Uharek, MD PhD

Principal Investigator

Bertram Glass, Prof. Dr.		Ph: ++49-40-1818853537
		Email: b.glass@asklepios.com

Germany
	Göttingen
		Alexander Berg	Ph: ++49-551-3913497
			Email: berg.ifs@med.uni-goettingen.de
	Institut für anwendungsorientierte Forschung und klinische Studien (IFS gGmbH)
		Bertram Glass, MD, PhD	Ph: ++49-40-1818853537
			Email: b.glass@asklepios.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00521560
Information obtained from ClinicalTrials.gov on March 18, 2009