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A Study of Zevalin and Simultaneous Application of BEAM High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation in Refractory and Relapsed Aggressive Non-Hodgkin Lymphomas (escZ-BEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521560
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Brief 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

Condition or disease Intervention/treatment Phase
Primary Non-Hodgkin-Lymphoma Refractory Non-Hodgkin-Lymphoma CD20+ Aggressive Non-Hodgkin's Lymphoma Drug: Zevalin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/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
Study Start Date : March 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1 Drug: Zevalin

All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively.

High dose therapy will be given as BEAM

Other Name: 90Y-Ibritumomab-Tiuxetan

Primary Outcome Measures :
  1. The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation. [ Time Frame: 3 Year ]

Secondary Outcome Measures :
  1. Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney [ Time Frame: 3 Years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521560

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Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)
Göttingen, Germany, 37075
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
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Study Director: Bertram Glass, Prof. Dr. German Society of Cancer e.V.
Principal Investigator: Martin Gramatzki, MD PhD Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, Germany
Principal Investigator: Mattias Witzens Harig, MD PhD Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, Germany
Principal Investigator: Bernd Hertenstein, MD PhD Klinikum Bremen-Mitte gGmbH, Medizinische Klinik I, Bremen, Germany
Principal Investigator: Georg Heß, MD PhD III Med., Schwerpunkt Hämatologie / Onkologie, Mainz, Germany
Principal Investigator: Dorothea Kofahl-Krause, MD PhD MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, Germany
Principal Investigator: Norbert Schmitz, MD PhD Asklepios Klinik St. Georg, Hämatologische Abt., Hamburg, Germany
Principal Investigator: Jörg Schubert, MD PhD Universitätskliniken d. Saarlandes, Med. I, Homburg/Saar, Germany
Principal Investigator: Lutz Uharek Uharek, MD PhD Charité - Campus Benjamin Franklin, Med. III, Berlin, Germany
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Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH Identifier: NCT00521560    
Other Study ID Numbers: DSHNHL 2004-R4
DSHNHL 2004-R4
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
High-Dose Radio-Immuno- and Chemotherapy
stem cell transplantation
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms