Treatment for Advanced B-Cell Lymphoma
Treatment for Advanced B-Cell Lymphoma
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).
Inclusion Criteria:

 -  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.

 B-Cell Anaplastic Large cell Ki 1 positive lymphomas, Primary Mediastinal B-Cell Lymphoma
 (PMBL), and B-Lymphoblastic lymphomas are ineligible.

 No previous chemotherapy. Patients who have received emergency irradiation and/or steroid
 therapy will be eligible ONLY if started on protocol therapy not more than 72 hours from
 the start of radiotherapy or steroids. Bone marrow and cerebrospinal fluid MUST be obtained
 before steroids are given for patient to be eligible for the study.

 Exclusion Criteria:

 -  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).

 4.2.6 Patients with serious (sepsis, pneumonia, etc..) proven or suspected infections at
 diagnosis will be excluded.

 4.2.7 Pregnancy or Breast-Feeding: No information is available regarding human fetal or
 teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal.
 Males or females of reproductive potential may not participate unless they have agreed to
 use an effective contraceptive method.