NCT00324779

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_2 leukemia

Geographic Reach
2 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

7.1 years

First QC Date

May 10, 2006

Last Update Submit

September 24, 2015

Conditions

LeukemiaLymphoma

Keywords

B-cell childhood acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemiastage I childhood large cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphoma

Outcome Measures

Primary Outcomes (5)

  • Response rate

  • Effect of rituximab on different histological subtypes

  • Rituximab response

  • Toxicity

  • Pharmacokinetics and pharmacodynamics

Interventions

rituximabBIOLOGICAL

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (38)

Kinderklinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Klinikum Augsburg

Augsburg, DOH-86156, Germany

Location

Charite - Campus Charite Mitte

Berlin, D-10117, Germany

Location

Helios Klinikum Berlin

Berlin, D-13125, Germany

Location

Evangelisches Krankenhauus Bielfeld

Biefeld, 33617, Germany

Location

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

Location

Children's Hospital

Cologne, D-50924, Germany

Location

Vestische Kinderklinik

Datteln, 45704, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99089, Germany

Location

Universitaets - Kinderklinik

Erlangen, 91054, Germany

Location

Universitaetsklinikum Essen

Essen, D-45147, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Kinderklinik

Giessen, D-35385, Germany

Location

Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald

Greifswald, 17475, Germany

Location

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitaets - Kinderklinik

Jena, D-07440, Germany

Location

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

Location

Kinderkrankenhaus Park Schoenfeld

Kassel, D-34121, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Universitaets - Kinderklinik

Leipzig, D-04317, Germany

Location

Universitaets - Kinderklinik - Luebeck

Lübeck, D-23538, Germany

Location

Universitatsklinikum der MA

Magdeburg, 39120, Germany

Location

Universitaets - Kinderklinik

Marburg, 35033, Germany

Location

Krankenhaus Muenchen Schwabing

Munich, 80804, Germany

Location

Dr. von Haunersches Kinderspital der Universitaet Muenchen

Munich, D-80337, Germany

Location

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Münster, D-48149, Germany

Location

Cnopf'sche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinik St. Hedwig-Kinderklinik

Regensburg, 93049, Germany

Location

Olgahospital

Stuttgart, D-70176, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89075, Germany

Location

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

MeSH Terms

Conditions

LeukemiaLymphomaDendritic Cell Sarcoma, InterdigitatingBurkitt Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHistiocytic Disorders, MalignantHistiocytosisEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Alfred Reiter, MD

    University Hospital Erlangen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

March 1, 2004

Primary Completion

April 1, 2011

Last Updated

September 25, 2015

Record last verified: 2015-09

Locations

CH(1)DE(37)