Clinical trial NCT00324779: Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Official title: Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Lymphoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-05-11
Enrollment: 79
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Response rate
measure: Effect of rituximab on different histological subtypes
measure: Rituximab response
measure: Toxicity
measure: Pharmacokinetics and pharmacodynamics
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Kinderklinik - Universitaetsklinikum Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charite - Campus Charite Mitte
city: Berlin
country: Germany
facility: Helios Klinikum Berlin
city: Biefeld
country: Germany
facility: Evangelisches Krankenhauus Bielfeld
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte
city: Cologne
country: Germany
facility: Children's Hospital
city: Datteln
country: Germany
facility: Vestische Kinderklinik
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Erlangen
country: Germany
facility: Universitaets - Kinderklinik
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe Universitaet
city: Freiburg
country: Germany
facility: Universitaetskinderklinik - Universitaetsklinikum Freiburg
city: Giessen
country: Germany
facility: Kinderklinik
city: Greifswald
country: Germany
facility: Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
city: Hamburg
country: Germany
facility: University Medical Center Hamburg - Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitaets-Kinderklinik Heidelberg
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitaets - Kinderklinik
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe gGmbH
city: Kassel
country: Germany
facility: Kinderkrankenhaus Park Schoenfeld
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein - Kiel Campus
city: Leipzig
country: Germany
facility: Universitaets - Kinderklinik
city: Luebeck
country: Germany
facility: Universitaets - Kinderklinik - Luebeck
city: Magdeburg
country: Germany
facility: Universitatsklinikum der MA
city: Marburg
country: Germany
facility: Universitaets - Kinderklinik
city: Muenster
country: Germany
facility: Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
city: Munich
country: Germany
facility: Krankenhaus Muenchen Schwabing
city: Munich
country: Germany
facility: Dr. von Haunersches Kinderspital der Universitaet Muenchen
city: Nuremberg
country: Germany
facility: Cnopf'sche Kinderklinik
city: Regensburg
country: Germany
facility: Klinik St. Hedwig-Kinderklinik
city: Stuttgart
country: Germany
facility: Olgahospital
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
city: Wuerzburg
country: Germany
facility: Universitaets - Kinderklinik Wuerzburg
city: Zurich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Hospital Erlangen
name: Alfred Reiter, MD
role: STUDY_CHAIR
References: