Reduced Burden of Oncologic Therapy in Advanced B-cell Lymphoma (REBOOT ABLY) in Children, Adolescents and Young Adults With CD20+ Mature B-Cell Lymphoma
- Newly diagnosed mature B-lineage (CD20 positive) Leukemia/Lymphoma
- 1. Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -2.
- 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.
- 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
- 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.