Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia - Full Text View

Sponsored by:	Kinderklinik
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00324779

Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving rituximab before chemotherapy may be an effective treatment for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.

PURPOSE: This phase II trial is studying how well rituximab works in treating young patients who are planning to receive chemotherapy for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.

Condition	Intervention	Phase
Leukemia Lymphoma	Biological: rituximab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Effect of rituximab on different histological subtypes [ Designated as safety issue: No ]
Rituximab response [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Pharmacokinetics and pharmacodynamics [ Designated as safety issue: No ]

Estimated Enrollment:	79
Study Start Date:	March 2004

Detailed Description:

OBJECTIVES:

Determine the response rate in children and adolescents with B-cell non-Hodgkin's lymphoma (B-NHL) or B-cell acute lymphoblastic leukemia (B-ALL) treated with rituximab monotherapy as upfront window therapy before chemotherapy.
Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen.
Investigate the rituximab response in patients treated with this regimen.
Determine the toxicity profile of rituximab in these patients.
Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1.

PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically and immunohistochemically OR cytomorphologically and immunphenotypically confirmed mature B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia
CD20 positive disease

PATIENT CHARACTERISTICS:

Not pregnant or nursing
Fertile patients must use effective contraception
Adequate general condition with sufficient organ function (hepatic, renal, and cardiac)
No known disease that would preclude protocol therapy with rituximab
No known allergies against proteins
No acute or previous hepatitis B infection

PRIOR CONCURRENT THERAPY:

At least 2 weeks since prior corticosteroids
No prior radiotherapy
No prior or concurrent chemotherapy
No concurrent treatment in another investigational trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324779

Locations

Germany
Charite - Campus Charite Mitte	Recruiting
Berlin, Germany, D-10117
Contact: Gunter Henze 49-304-5056-6152
Children's Hospital	Recruiting
Cologne, Germany, D-50924
Contact: Frank Berthold, MD 49-221-478-4380 frank.berthold@uk-koeln.de
Cnopf'sche Kinderklinik	Recruiting
Nuremberg, Germany, 90419
Contact: A. Jobke 49-911-3340-02
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm	Recruiting
Ulm, Germany, D-89075
Contact: Klaus M. Debatin, MD 49-731-5002-7790 klaus-michael.debatin@medizin.uni-ulm.de
Dr. von Haunersches Kinderspital der Universitaet Muenchen	Recruiting
Munich, Germany, D-80337
Contact: Arndt Borkhardt 49-89-5160-4498
Evangelisches Krankenhauus Bielfeld	Recruiting
Biefeld, Germany, 33617
Contact: N. Jorch, MD 49-52-177-278-050
Helios Klinikum Berlin	Recruiting
Berlin, Germany, D-13125
Contact: L. Wickmann, MD 49-309-401-2359 lwickmann@berlin.helios-kliniken.de
Helios Klinikum Erfurt	Recruiting
Erfurt, Germany, 99089
Contact: Axel Sauerbrey, MD 49-361-781-3729 asauerbrey@erfurt.helios-kliniken.de
Kinderklinik - Universitaetsklinikum Aachen	Recruiting
Aachen, Germany, D-52074
Contact: R. Mertens, MD, PhD 49-241-808-9902 rmertens@ukaachen.de
Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, D-30625
Contact: Karl Welte, MD 49-511-532-6710 welte.karl.h@mh-hannover.de
Kinderkrankenhaus Park Schoenfeld	Recruiting
Kassel, Germany, D-34121
Contact: F. K. Tegtmeyer, MD 49-561-928-5313 fk.tegtmeyer@park-shoenfeld.de
Klinik St. Hedwig-Kinderklinik	Recruiting
Regensburg, Germany, 93049
Contact: Ove Peters 49-941-369-5404
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster	Recruiting
Muenster, Germany, D-48149
Contact: Heribert F. Juergens, MD 49-251-834-7742 jurgh@uni-muenster.de
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald	Recruiting
Greifswald, Germany, 17475
Contact: F. Beck 49-3834-86-6324 ext. 6325
Klinikum Augsburg	Recruiting
Augsburg, Germany, DOH-86156
Contact: Astrid Gnekow 49-821-400-3603
Klinikum Bremen-Mitte	Recruiting
Bremen, Germany, D-28205
Contact: Arnulf Pekrun, MD, PhD 49-421-497-3656 arnulf.pekrun@klinikum-bremen-mitte.de
Klinikum der J.W. Goethe Universitaet	Recruiting
Frankfurt, Germany, D-60590
Contact: Thomas Klingebiel, MD 49-69-6301-5094 thomas.klingebiel@kgu.de
Krankenhaus Muenchen Schwabing	Recruiting
Munich, Germany, 80804
Contact: Stefan Burdach, MD, PhD 49-89-3068-2352
Kinderklinik	Recruiting
Giessen, Germany, D-35385
Contact: Alfred Reiter, MD 49-641-994-3420
Olgahospital	Recruiting
Stuttgart, Germany, D-70176
Contact: Stefan Bielack, MD 49-711-99-24-61 st.bielack@olgahospital.de
Staedtisches Klinikum Karlsruhe gGmbH	Recruiting
Karlsruhe, Germany, 76133
Contact: A. Leipold 49-721-974-3311
Universitaets - Kinderklinik - Luebeck	Recruiting
Luebeck, Germany, D-23538
Contact: Peter P. Bucsky, MD 49-451-500-2956 bucsky@paedia.ukl.mu-luebeck.de
Universitaets - Kinderklinik Wuerzburg	Recruiting
Wuerzburg, Germany, D-97080
Contact: P. G. Schlegel, MD 49-931-201-27-831 schlegel@mail.uni-wuerzburg.de
Universitaets - Kinderklinik	Recruiting
Jena, Germany, D-07440
Contact: Contact Person 49-3641-938-270
Universitaets-Kinderklinik Heidelberg	Recruiting
Heidelberg, Germany, D-69120
Contact: Andreas E. Kulozik, MD, PhD 49-6221-564-555 andreas.kulozik@med.uni-heidelberg.de
Universitaets - Kinderklinik	Recruiting
Leipzig, Germany, D-04317
Contact: Dieter Koerholz, MD 49-341-9726-246 koerd@medizin.uni-leipzig.de
Universitaets - Kinderklinik	Recruiting
Marburg, Germany, 35033
Contact: H. Christiansen, MD 49-6421-286-2650
Universitaetskinderklinik - Universitaetsklinikum Freiburg	Recruiting
Freiburg, Germany, D-79106
Contact: Charlotte Niemeyer, MD 49-761-270-4506 charlotte.niemeyer@uniklinik-freiburg.de
Universitaets - Kinderklinik	Recruiting
Erlangen, Germany, 91054
Contact: W. Nolter, MD 49-9131-853-3785
Universitaetsklinikum des Saarlandes	Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf 49-6841-162-4000
Universitaetsklinikum Essen	Recruiting
Essen, Germany, D-45147
Contact: Bernhard Kremens, MD 49-201-723-2453
Universitaetsklinikum Tuebingen	Recruiting
Tuebingen, Germany, D-72076
Contact: Rupert Handgretinger, MD 49-7071-298-2087
Universitatsklinikum Carl Gustav Carus	Recruiting
Dresden, Germany, D-01307
Contact: M. Suttorp, MD 49-351-458-0 meinolf.suttorp@uniklinikum-dresden.de
Universitatsklinikum der MA	Recruiting
Magdeburg, Germany, 39120
Contact: Uwe Mittler, MD 49-391-67-17210
University Hospital Schleswig-Holstein - Kiel Campus	Recruiting
Kiel, Germany, D-24105
Contact: Martin Schrappe, MD, PhD 49-431-597-1620
University Medical Center Hamburg - Eppendorf	Recruiting
Hamburg, Germany, D-20246
Contact: Gritta Janka-Schaub 49-404-2803-2580
Vestische Kinderklinik	Recruiting
Datteln, Germany, 45704
Contact: W. Andler, MD 49-023-63-9750 w.andler@kinderklinik-datteln.de
Switzerland
University Children's Hospital	Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD 41-44-266-7823

Sponsors and Collaborators

Kinderklinik

Investigators

Study Chair:

Alfred Reiter, MD

Kinderklinik

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000466643, B-NHL-BFM-Rituximab, EU-205119, NHL-BFM-RITUXIMAB
Study First Received:	May 10, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00324779 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
stage I childhood large cell lymphoma
stage II childhood large cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood large cell lymphoma
stage I childhood lymphoblastic lymphoma

stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
stage I childhood small noncleaved cell lymphoma
stage II childhood small noncleaved cell lymphoma
stage III childhood small noncleaved cell lymphoma
stage IV childhood small noncleaved cell lymphoma

Study placed in the following topic categories:

Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Immunologic Factors
Lymphoblastic Lymphoma
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Epstein-Barr Virus Infections
Lymphoma, Large-cell
Lymphoma
Acute Lymphoblastic Leukemia
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders
Rituximab
Small Non-cleaved Cell Lymphoma
Herpesviridae Infections
Virus Diseases
Lymphatic Diseases
Burkitt's Lymphoma
B-cell Lymphomas
Burkitt Lymphoma
DNA Virus Infections
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:

Leukemia, Lymphoid
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Tumor Virus Infections
Neoplasms, Experimental
Lymphoma, B-Cell
Leukemia
Therapeutic Uses
Epstein-Barr Virus Infections
Lymphoma
Neoplasms by Histologic Type
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders
Immune System Diseases
Rituximab
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Lymphatic Diseases
Neoplasms
Burkitt Lymphoma
DNA Virus Infections
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 01, 2009