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

August 27, 2007
February 13, 2013
March 2006
August 2009   (final data collection date for primary outcome measure)
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 ]
Freedom from treatment failure (TTF)
Complete list of historical versions of study NCT00521560 on ClinicalTrials.gov Archive Site
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 ]
Treatment related mortality (TRM), freedom from progression (FFP), Sur-vival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney
Not Provided
Not Provided
 
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
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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Non-Hodgkin-Lymphoma
  • Refractory Non-Hodgkin-Lymphoma
  • CD20+ Aggressive Non-Hodgkin`s Lymphoma
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
Experimental: 1
Intervention: Drug: Zevalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2012
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00521560
DSHNHL 2004-R4, DSHNHL 2004-R4
Yes
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Not Provided
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
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP