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Lead
University Hospital Erlangen
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.
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
