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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

NCT00521560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-02-15

No results posted yet for this study

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

Conditions

  • Primary Non-Hodgkin-Lymphoma
  • Refractory Non-Hodgkin-Lymphoma
  • CD20+ Aggressive Non-Hodgkin's Lymphoma

Interventions

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

Sponsors & Collaborators

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    lead OTHER

Principal Investigators

  • Bertram Glass, Prof. Dr. · German Society of Cancer e.V.

  • Martin Gramatzki, MD PhD · Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, Germany

  • Mattias Witzens Harig, MD PhD · Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, Germany

  • Bernd Hertenstein, MD PhD · Klinikum Bremen-Mitte gGmbH, Medizinische Klinik I, Bremen, Germany

  • Georg Heß, MD PhD · III Med., Schwerpunkt Hämatologie / Onkologie, Mainz, Germany

  • Dorothea Kofahl-Krause, MD PhD · MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, Germany

  • Norbert Schmitz, MD PhD · Asklepios Klinik St. Georg, Hämatologische Abt., Hamburg, Germany

  • Jörg Schubert, MD PhD · Universitätskliniken d. Saarlandes, Med. I, Homburg/Saar, Germany

  • Lutz Uharek Uharek, MD PhD · Charité - Campus Benjamin Franklin, Med. III, Berlin, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-08-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00521560 on ClinicalTrials.gov