Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
N/A
18 Years
Both
Leukemia, Lymphoma
Trial Information
Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Alfred Reiter, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kinderklinik
Authority:
United States: Federal Government
Study ID:
CDR0000466643
NCT ID:
NCT00324779
Start Date:
March 2004
Completion Date:
Related Keywords:
- Leukemia
- Lymphoma
- 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
- Burkitt Lymphoma
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
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