LeukemiaPhase 2NCT00324779
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
A Phase 2 study testing rituximab in people with Leukemia and Lymphoma, run by University Hospital Erlangen at 38 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- What is being tested?
- rituximab
- How many people
- 79 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Mar 2004to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
Germany37 sites
Kinderklinik - Universitaetsklinikum Aachen
Aachen, D-52074
Klinikum Augsburg
Augsburg, DOH-86156
Charite - Campus Charite Mitte
Berlin, D-10117
Helios Klinikum Berlin
Berlin, D-13125
Evangelisches Krankenhauus Bielfeld
Biefeld, 33617
Klinikum Bremen-Mitte
Bremen, D-28205
Children's Hospital
Cologne, D-50924
Vestische Kinderklinik
Datteln, 45704
Universitatsklinikum Carl Gustav Carus
Dresden, D-01307
Helios Klinikum Erfurt
Erfurt, 99089
Universitaets - Kinderklinik
Erlangen, 91054
Universitaetsklinikum Essen
Essen, D-45147
Klinikum der J.W. Goethe Universitaet
Frankfurt, D-60590
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, D-79106
Kinderklinik
Giessen, D-35385
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
Greifswald, 17475
University Medical Center Hamburg - Eppendorf
Hamburg, D-20246
Medizinische Hochschule Hannover
Hanover, D-30625
Universitaets-Kinderklinik Heidelberg
Heidelberg, D-69120
Universitaetsklinikum des Saarlandes
Homburg, 66421
Universitaets - Kinderklinik
Jena, D-07440
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133
Kinderkrankenhaus Park Schoenfeld
Kassel, D-34121
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24105
Universitaets - Kinderklinik
Leipzig, D-04317
Universitaets - Kinderklinik - Luebeck
Lübeck, D-23538
Universitatsklinikum der MA
Magdeburg, 39120
Universitaets - Kinderklinik
Marburg, 35033
Krankenhaus Muenchen Schwabing
Munich, 80804
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, D-80337
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Münster, D-48149
Cnopf'sche Kinderklinik
Nuremberg, 90419
Klinik St. Hedwig-Kinderklinik
Regensburg, 93049
Olgahospital
Stuttgart, D-70176
Universitaetsklinikum Tuebingen
Tübingen, D-72076
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89075
Universitaets - Kinderklinik Wuerzburg
Würzburg, D-97080
About this study
Official title: Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
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.
Read the 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.
- Being tested
- rituximab
- 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
- Medical subject headings
- Leukemia, Lymphoma, Dendritic Cell Sarcoma, Interdigitating, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Effect of rituximab on different histological subtypes
Rituximab response
Toxicity
Pharmacokinetics and pharmacodynamics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startMar 2004
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Investigators
- Alfred Reiter, MD, Study chair, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324779
- Sponsor's protocol ID
- CDR0000466643
- Other IDs
- B-NHL-BFM-Rituximab, EU-205119, NHL-BFM-RITUXIMAB
- Status last verified
- Sep 2015
- First submitted
- 10 May 2006
- Last updated
- 25 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
- ClinicalTrials.gov ID
- NCT00324779
- Acronym / sponsor ID
- CDR0000466643
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Apr 2011 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximab | Biological | – |
Primary outcome
Response rate
Effect of rituximab on different histological subtypes
Rituximab response
Toxicity
Pharmacokinetics and pharmacodynamics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Reiter, MD study chair
University Hospital Erlangen
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab in people with Leukemia and Lymphoma, run by University Hospital Erlangen at 38 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.