ANHL1131, Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma (NHL) or Mature B-cell Leukemia (B-AL): Evaluation of Rituximab Efficacy and Safety in High Risk Patients
- Children’s Medical Center (Dallas, Plano, Southlake)
all eligible participants with PMLBL will receive six courses of Da ePoCH chemotherapy plus a dose of rituximab during each course for a total of 6 doses. Participants will be asked if they are willing to provide blood samples at designated time points for additional research tests.
all eligible participants with B-nHL and B-aL will have tests done to determine their disease stage (where the cancer cells are in the body). Depending on the results of these tests, participants will be assigned to 1 of 3 groups:
Group B: Subjects who have advanced B-nHL (including those with less than 25% cancer cells in the bone marrow) but who do not have cancer cells in the brain or in the spinal fluid.
Group C1: Subjects who have more than or exactly 25% cancer cells in the bone marrow and/or have cancer cells in or around the brain or the spinal cord.
Group C3: Subjects who have cancer cells in the fluid around the spinal cord.
in each group (B, C1 and C3) half of the patients will be randomly assigned to receive the chemotherapy with rituximab while half will receive the chemotherapy without rituximab. all subjects randomized to receive rituximab will get a total of 6 doses given by injection into a vein. Two doses each will be during the 2 induction phases, and one dose each will be during the 2 Consolidation phases. The chemotherapy regimen for each group is different and is outlined below:
Group B: Standard B therapy is divided into a Pre-phase, followed by 2 courses of induction, and 2 courses of Consolidation. Subjects receive either of the following, depending on randomization:
Group B-arm 1: Standard B therapy. This is the standard arm. Group B-arm 2: Standard B therapy with the addition of rituximab. This is an experimental arm.
Group C1: Standard C1 therapy is divided into a Pre-phase, followed by 2 courses of induction, 2 courses of Consolidation and 2 courses of Maintenance. Subjects receive either of the following, depending on randomization:
Standard C1 therapy. This is the standard arm. Standard C1 therapy with the addition of rituximab. This is an experimental arm.
Group C3: Standard C3 therapy is divided into a Pre-phase, followed by 2 courses of induction, 2 courses of Consolidation and 2 courses of Maintenance. Subjects receive either of the following, depending on randomization:
Standard C3 therapy. This is the standard arm. Standard C3 therapy with the addition of rituximab. This is an experimental arm.
all participants will have tests done at designated time points during treatment to evaluate how their tumor is responding to treatment. Some participants may have standard PeT scans done as part of these tests. The researchers will record if PeT scans are done, and participants will have the option of sharing the results of the PeT scans with the researchers. Study participants will also have the option of participating in additional biological research studies.
-- 6 months to less than 18 years of age at time of consent
-- Histologically or cytologically confirmation of PMLBL or advanced B-cell NHL or B-AL
-- Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate
-- Complete initial work-up within 8 days prior to treatment that allows definite staging
-- Able to comply with scheduled follow-up and with management of toxicity
-- Signed informed consent from patients and/or their parents or legal guardians