A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia / Lymphoma Treated with LMB / FAB Therapy
What is the purpose of this study?
- To determine if there are any harmful side effects of adding rituximab and rasburicase to the standard therapy. In addition, because we want to learn more about the biology of B-cell leukemia/ lymphoma, there are two other goals:
- To compare the amount of disease cells present in the body before, during, and after therapy.
- To find out if there are proteins or genetic information in the tumor cells that can tell us the best way to treat children with B-cell leukemia/lymphoma.
Who will be included in this study?
Patients who are between the ages of 1 and 29 years old who have a type of acute lymphoblastic leukemia (ALL) called B-cell leukemia or a type of non-Hodgkin's lymphoma (NHL) called B-cell lymphoma may be eligible to participate in this clinical trial.
What is involved?
There are four basic treatment plans on this study:
- Treatment 1, Group B sub-pilot, for the first six Group B patients who are enrolled on study
- Treatment 2, Group B pilot, for the rest of the Group B patients who are enrolled on study
- Treatment 3, Group C sub-pilot, for the first three Group C patients who are enrolled on study
- Treatment 4, Group C pilot, for the rest of the Group C patients who are enrolled on the study
Before treatment on this study begins, and while receiving treatment, patients will receive a series of standard medical tests:
- Medical history
- Physical exam
- Frequent blood tests
- Urine tests
- Bone marrow examinations
- Spinal taps
- X-rays and other scans
- Tests of heart function
- Optional research studies
What are the benefits?
Participants who agree to take part in this research study may or may not experience a direct medical benefit. We do not know if the addition of rituximab to chemotherapy will improve the cure rate of leukemia/lymphoma. The information learned from this research study may benefit other patients with B-cell leukemia or B-cell lymphoma in the future.
Will I get all the facts about the study?
Parents interested in having their child participate will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/patient and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
A detailed list of side effects will be provided to those patients interested in knowing more about the study.
Who should I contact for more information?
Peggy Kaiser, RN, BSN
Cincinnati Children's Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
