Back to resultsRituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Primary Purpose
Leukemia, Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
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
Sites / Locations
- Kinderklinik - Universitaetsklinikum Aachen
- Klinikum Augsburg
- Charite - Campus Charite Mitte
- Helios Klinikum Berlin
- Evangelisches Krankenhauus Bielfeld
- Klinikum Bremen-Mitte
- Children's Hospital
- Vestische Kinderklinik
- Universitatsklinikum Carl Gustav Carus
- Helios Klinikum Erfurt
- Universitaets - Kinderklinik
- Universitaetsklinikum Essen
- Klinikum der J.W. Goethe Universitaet
- Universitaetskinderklinik - Universitaetsklinikum Freiburg
- Kinderklinik
- Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
- University Medical Center Hamburg - Eppendorf
- Medizinische Hochschule Hannover
- Universitaets-Kinderklinik Heidelberg
- Universitaetsklinikum des Saarlandes
- Universitaets - Kinderklinik
- Staedtisches Klinikum Karlsruhe gGmbH
- Kinderkrankenhaus Park Schoenfeld
- University Hospital Schleswig-Holstein - Kiel Campus
- Universitaets - Kinderklinik
- Universitaets - Kinderklinik - Luebeck
- Universitatsklinikum der MA
- Universitaets - Kinderklinik
- Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
- Krankenhaus Muenchen Schwabing
- Dr. von Haunersches Kinderspital der Universitaet Muenchen
- Cnopf'sche Kinderklinik
- Klinik St. Hedwig-Kinderklinik
- Olgahospital
- Universitaetsklinikum Tuebingen
- Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
- Universitaets - Kinderklinik Wuerzburg
- University Children's Hospital
Outcomes
Primary Outcome Measures
Response rate
Effect of rituximab on different histological subtypes
Rituximab response
Toxicity
Pharmacokinetics and pharmacodynamics
Secondary Outcome Measures
Full Information
NCT ID
NCT00324779
First Posted
May 10, 2006
Last Updated
September 24, 2015
Sponsor
University Hospital Erlangen
1. Study Identification
Unique Protocol Identification Number
NCT00324779
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Erlangen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
79 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
rituximab
Primary Outcome Measure Information:
Title
Response rate
Title
Effect of rituximab on different histological subtypes
Title
Rituximab response
Title
Toxicity
Title
Pharmacokinetics and pharmacodynamics
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Reiter, MD
Organizational Affiliation
University Hospital Erlangen
Official's Role
Study Chair
Facility Information:
Facility Name
Kinderklinik - Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
DOH-86156
Country
Germany
Facility Name
Charite - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Helios Klinikum Berlin
City
Berlin
ZIP/Postal Code
D-13125
Country
Germany
Facility Name
Evangelisches Krankenhauus Bielfeld
City
Biefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
D-28205
Country
Germany
Facility Name
Children's Hospital
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Vestische Kinderklinik
City
Datteln
ZIP/Postal Code
45704
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitaets - Kinderklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45147
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Universitaetskinderklinik - Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Kinderklinik
City
Giessen
ZIP/Postal Code
D-35385
Country
Germany
Facility Name
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
University Medical Center Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Universitaets-Kinderklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitaets - Kinderklinik
City
Jena
ZIP/Postal Code
D-07440
Country
Germany
Facility Name
Staedtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Kinderkrankenhaus Park Schoenfeld
City
Kassel
ZIP/Postal Code
D-34121
Country
Germany
Facility Name
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Universitaets - Kinderklinik
City
Leipzig
ZIP/Postal Code
D-04317
Country
Germany
Facility Name
Universitaets - Kinderklinik - Luebeck
City
Luebeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
Universitatsklinikum der MA
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitaets - Kinderklinik
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Krankenhaus Muenchen Schwabing
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Dr. von Haunersches Kinderspital der Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-80337
Country
Germany
Facility Name
Cnopf'sche Kinderklinik
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Klinik St. Hedwig-Kinderklinik
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Olgahospital
City
Stuttgart
ZIP/Postal Code
D-70176
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89075
Country
Germany
Facility Name
Universitaets - Kinderklinik Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
University Children's Hospital
City
Zurich
ZIP/Postal Code
CH-8032
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
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