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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT00521560
First received: August 27, 2007
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Primary Non-Hodgkin-Lymphoma
Refractory Non-Hodgkin-Lymphoma
CD20+ Aggressive Non-Hodgkin`s Lymphoma
Drug: Zevalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: March 2006
Study Completion Date: August 2012
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521560

Locations
Germany
Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH)
Göttingen, Germany, 37075
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT00521560     History of Changes
Other Study ID Numbers: DSHNHL 2004-R4, DSHNHL 2004-R4
Study First Received: August 27, 2007
Last Updated: February 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection
Germany: Paul-Ehrlich-Institut

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
High-Dose Radio-Immuno- and Chemotherapy
stem cell transplantation
90Y-Ibritumomab-Tiuxetan

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014