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)

February 13, 2013 updated by: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 90Y-Ibritumomab-Tiuxetan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 Year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSHNHL 2004-R4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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