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 - Full Text View

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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Ibritumomab tiuxetan

U.S. FDA Resources

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:

Lymphoma, Non-Hodgkin
Aggression
Lymphoma
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 June 18, 2013

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)