Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma
About this trial
This is an interventional treatment trial for B-cell Childhood Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria: Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia CD20+ (confirmed by flow cytometry of tumor tissue, involved marrow, or CD20 immunostaining) The following histologies are generally CD20+ and are eligible: Diffuse large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma, or follicular lymphoma, grade III (rare), documented by flow cytometry or appropriate immunohistochemistry, any stage Burkitt's lymphoma or atypical Burkitt's/Burkitt-like lymphoma, any stage B-cell acute lymphoblastic leukemia, with FABL3 morphology and/or demonstration of surface immunoglobin by flow cytometry Atypical precursor B-cell lymphoblastic lymphoma or other unusual histologies that are CD20+ Measurable disease by clinical, radiographic, or histologic criteria Must be in first or later recurrence or have disease that is primarily refractory to conventional therapy No isolated CNS disease Performance status - ECOG 0-2 At least 2 months Absolute neutrophil count ≥ 1,000/mm^3* Platelet count ≥ 100,000/mm^3 (transfusion independent)* Hemoglobin ≥ 10.0 g/dL (RBC transfusion allowed)* Bilirubin ≤ 1.5 times normal ALT < 2.5 times normal No chronic renal insufficiency Renal insufficiency allowed provided it is secondary to tumor lysis syndrome Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment HIV negative No active uncontrolled infection Seizure disorder allowed if well controlled with anticonvulsants No CNS toxicity greater than grade II At least 24 hours since prior growth factor(s) At least 60 days since prior biologic (antineoplastic) therapy Prior stem cell transplantation allowed provided the following criteria are met: More than 60 days since transplantation Hematopoietic lab value requirements are met (See Hematopoietic) No evidence of graft-versus-host disease (if post-allogeneic transplantation) Prior monoclonal antibody therapy allowed (including rituximab) No other concurrent immunomodulating agents More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) No other concurrent chemotherapy No concurrent steroids (except for rituximab infusion-related symptoms) At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis Concurrent radiotherapy to localized painful, airway-compromising, or other acute organ-threatening lesions allowed provided at least 1 measurable lesion is not irradiated Recovered from prior therapy No concurrent participation in another phase II study
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy, rituximab)
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.