Treatment for Advanced B-Cell Lymphoma
Trial Status: Complete
To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy).
- Newly diagnosed mature B-lineage (CD20 positive) Leukemia/Lymphoma
- 1. Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -2. Burkitt's Lymphoma
- 3. High Grade B-cell Lymphoma---Burkitt's like.
- Patients with newly diagnosed Group A (low risk) lymphoma. Patients with Group B (intermediate risk) if classified as Murphy Stage III/IV and diagnostic LDH > 2 XULN and patients with primary mediastinal B-cell lymphoma (PMBL).
- Patients who have received any steroids in the week prior to diagnosis except as stated in Section 4.1.4 of the protocol.
- No congenital or acquired immune deficiency. These patients are excluded due to the expected intense immunosuppression, increased risk of opportunistic infections, and higher expected septic death rate in this subgroup of patients with this proposed therapy.
- No prior solid organ transplantation.
- Patients with previous malignancies that have been treated with systemic chemotherapy with alkylator or anthracycline therapy. The latter group of patients are excluded due to an expected increase in late effects (eg. late cardiac toxicity, secondary malignancies, sterility, etc.).
- Patients with known G6PD deficiency are NOT ELIGIBLE for Rasburicase therapy. Patients with G6PD deficiency should be treated with alkalinization, IV hydration and po and/or IV allopurinol during the reduction phase (COP).
Rutgers Cancer Institute of New Jersey
Roswell Park Cancer Institute
Contact: Matthew J. Barth
University of Oklahoma Health Sciences Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Contact: Phillip Evan Barnette
Trial Phase Phase II
Trial Type Treatment
New York Medical College
- Primary ID NYMC-157
- Secondary IDs NCI-2015-01702, L 10,753
- Clinicaltrials.gov ID NCT01859819