A Phase II Study of Rituximab (IND#7028) and Ifosfamide, Carboplatin and Etoposide (ICE) Chemotherapy in Children With Recurrent/Refractory B-cell (CD20+) Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia
I. Determine the response of pediatric patients with relapsed or refractory B-cell
non-Hodgkin's lymphoma or acute lymphoblastic leukemia treated with ifosfamide, carboplatin,
and etoposide combined with rituximab.
II. Determine the relapse-free survival rate of patients treated with this regimen.
III. Determine the toxicity profile of this regimen in these patients, specifically the
frequency of therapy delays between courses due to prolonged grade IV hematologic toxicity.
I. Determine whether this regimen plus filgrastim (G-CSF) will result in mobilization of
greater than 2 X 10^6/kg peripheral blood stem cells (CD34+ cells, PBSC) in at least 80% of
patients for whom peripheral stem cell collection is performed.
II. Determine the time course of engraftment for patients who undergo peripheral stem cell
transplantation after collection of stem cells using this mobilization regimen.
OUTLINE: This is a multicenter study. Patients are stratified by disease (B-cell large cell
lymphoma or atypical precursor B-cell lymphoblastic lymphoma vs small non-cleaved cell
lymphoma or B-cell acute lymphoblastic leukemia).
Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5,
rituximab IV on days 1 and 3, and carboplatin IV over 1 hour on day 3. Patients receive
filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood
counts recover. Patients also receive intrathecal (IT) chemotherapy comprising methotrexate
and cytarabine. Patients with B-cell large cell lymphoma and negative CSF cytology receive
IT chemotherapy on day 3 of the first course only. Patients with small non-cleaved cell
lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT
chemotherapy on day 3. All patients with positive CSF cytology receive IT chemotherapy on
days 3, 10, and 17 of the first and second courses. Treatment repeats every 23 days for up
to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per disease stratum) will be accrued for
this study within 2-4 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate determined by physical exam and appropriate imaging studies
Response rates and confidence intervals will be constructed according to the method of Chang and O'Brien.
Up to 3 years
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|